Medical Devices

Virtual Incision Announces Publication of Data from its U.S. Investigational Device Exemption Study in the Clinical Journal, Diseases of Colon and Rectum

Retrieved on: 
Tuesday, April 30, 2024
Medical Devices, Health, Surgery, Health Technology, Clinical Trials, General Health, Colorectal surgery, FDA, Lankenau Medical Center, Learning, Safety, Food, IDE, Surgeon, MD, Trial of the century, Doctor of Philosophy, FACS, MIRA, Incidence, Patient, De novo, Aes, Investigational device exemption, Quality of life

Virtual Incision Corporation , the developer of the MIRA™ Surgical System (MIRA), today announced data from its Investigational Device Exemption (IDE) clinical study has been published in Diseases of Colon and Rectum .

Key Points: 
  • Virtual Incision Corporation , the developer of the MIRA™ Surgical System (MIRA), today announced data from its Investigational Device Exemption (IDE) clinical study has been published in Diseases of Colon and Rectum .
  • The study was designed to assess the safety and efficacy of MIRA, the world’s first miniaturized robotic-assisted surgery device, in adults undergoing colectomy procedures.
  • Results were provided to the Food and Drug Administration (FDA) as part of the submission to support the de novo marketing authorization of the device.
  • The data demonstrated the following results:
    The primary efficacy endpoint, the successful completion of pre-defined procedural steps without conversion to open surgery, was met.

Shore Capital Partners Announces Partnership with PRO-spectus

Retrieved on: 
Tuesday, April 30, 2024
Medical Devices, Finance, Consulting, Professional Services, Practice Management, Other Health, Biotechnology, Pharmaceutical, Health, Other Professional Services, Investment, Policy, Partnership, Business, Growth, SVP, Patient, Multimedia

Shore Capital Partners (“Shore” or “Shore Capital”), is pleased to announce it has completed a partnership with PRO-spectus (“the Company”), a provider of market access consulting and patient services headquartered in Huntington Beach, California.

Key Points: 
  • Shore Capital Partners (“Shore” or “Shore Capital”), is pleased to announce it has completed a partnership with PRO-spectus (“the Company”), a provider of market access consulting and patient services headquartered in Huntington Beach, California.
  • View the full release here: https://www.businesswire.com/news/home/20240430291874/en/
    Founded in 2008, PRO-spectus helps biopharmaceutical companies, medical device manufacturers, and diagnostic firms overcome barriers that stand between products and patients.
  • “We couldn’t be more excited about our partnership with Charmie and the PRO-spectus team.
  • Through our partnership, we are prepared to support PRO-spectus in reaching our shared objectives for long-term growth,” said Ryan Kelley, a Founding Partner of Shore and Chairman of PRO-spectus.

Desktop Health™ Announces Flexcera™ Family Resins Validated for Asiga® 3D Printers, Increasing Global Access to Premium Digital Dental Applications

Retrieved on: 
Tuesday, April 30, 2024
Biotechnology, Technology, FDA, Other Health, Health, Health Technology, Other Technology, Medical Devices, Dental, Hardware, Clinical Trials, Desktop Metal, Pro, Crown, Ultra, ISO, 3D, Gold, Patient, Dentures, Multimedia, Beauty, 3D printing

View the full release here: https://www.businesswire.com/news/home/20240430264785/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240430264785/en/
    Desktop Health's popular Flexcera family of nanoceramic resins, which are FDA 510(k) cleared for 3D printed dental prosthetics, are now validated for Asiga-brand dental 3D printers such as the Max UV, Max 2, Ultra, and Pro 4K.
  • This proprietary dental resin has been growing since its 2021 launch, delivering 3D printed permanent and temporary restorations, including dentures, crowns, bridges, veneers and more.
  • "We are extremely pleased by the exceptional performance of our Flexcera family of dental resins,” said Lou Azzara, President of Desktop Health.
  • “By expanding access to our world-class solutions, we're empowering dental laboratories and practices with groundbreaking innovations like Flexcera.

Axonics Reports First Quarter 2024 Financial Results

Retrieved on: 
Tuesday, April 30, 2024
Medical Supplies, Medical Devices, Health, Neurology, Health Technology, Biotechnology, Acquisition, Patient, Investment, Incontinence, Boston Scientific, Pharmaceutical industry

Axonics, Inc. (Nasdaq: AXNX), a medical technology company that develops and commercializes innovative and minimally invasive products to treat bladder and bowel dysfunction, today reported financial results for the three months ended March 31, 2024.

Key Points: 
  • Axonics, Inc. (Nasdaq: AXNX), a medical technology company that develops and commercializes innovative and minimally invasive products to treat bladder and bowel dysfunction, today reported financial results for the three months ended March 31, 2024.
  • “Our growth was driven by higher utilization and share of wallet for existing sacral neuromodulation customers and the onboarding of new accounts.
  • Due to the pending merger with Boston Scientific, Axonics stopped issuing new equity grants to employees as of January 2024.
  • Cash, cash equivalents, short-term investments and restricted cash were $349 million as of March 31, 2024.

908 Devices Reports First Quarter 2024 Financial Results and Updates 2024 Revenue Outlook

Retrieved on: 
Tuesday, April 30, 2024
Research, Mobile, Wireless, Hardware, Pharmaceutical, Technology, Medical Devices, Health Technology, Science, Chemicals, Plastics, Biotechnology, Health, Other Science, Manufacturing, MASS, Acquisition, Webcast, Biophysical environment, Social, Traction, ESG, Growth, Video game

908 Devices Inc. (Nasdaq: MASS), a pioneer of purpose-built handheld and desktop devices for chemical and biochemical analysis, today reported financial results for the quarter ended March 31, 2024.

Key Points: 
  • 908 Devices Inc. (Nasdaq: MASS), a pioneer of purpose-built handheld and desktop devices for chemical and biochemical analysis, today reported financial results for the quarter ended March 31, 2024.
  • This was primarily driven by an increase in handheld devices revenue offset by a decrease in desktop devices revenue.
  • The installed base grew to 2,914 devices with 53 handheld devices and 8 desktop devices placed during the first quarter 2024.
  • 908 Devices will host a conference call to discuss the first quarter 2024 financial results before market open on Tuesday, April 30, 2024 at 5:30 am Pacific Time / 8:30 am Eastern Time.

Toku Inc. Secures FDA Breakthrough Designation for Technology that Identifies Chronic Kidney Disease Risk Through the Eye

Retrieved on: 
Tuesday, April 30, 2024
Software, Research, Optical, Medical Devices, Technology, Artificial Intelligence, Science, Biotechnology, FDA, Other Science, Health, Diabetes, Health policy, Nephrology, Kidney disease, Patient, Disorder, Population health, System, National Kidney Foundation, Risk, AI, Food, Kidney failure, Death, Health care, Breakthrough, Disease, CKD, Retina, Eye, Developed country, Kidney transplantation, Dialysis, Microangiopathy, Medicare, Multimedia, Chronic kidney disease, Overalls, Pharmaceutical industry

Toku, Inc., a commercial medical device company specializing in imaging technology and AI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its MyKidneyAI technology.

Key Points: 
  • Toku, Inc., a commercial medical device company specializing in imaging technology and AI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its MyKidneyAI technology.
  • MyKidneyAI uses AI to analyze retinal images collected at routine eye exams to detect elevated chronic kidney disease (CKD) risk in people with diabetes.
  • Toku developed MyKidneyAI to help identify individuals with diabetes who have elevated CKD risk via a simple eye exam available in eye care or primary care settings.
  • FDA's Breakthrough designation expedites the review process, shortening the time until technology reaches patients if cleared by the FDA.

Senseonics Holdings, Inc. Schedules First Quarter 2024 Earnings Release and Conference Call for May 13, 2024 at 4:30 P.M. Eastern Time

Retrieved on: 
Tuesday, April 30, 2024
Software, General Health, Health, Diabetes, Medical Devices, Health Technology, Technology, Apps, Applications, CGM, International, Publication, Webcast, Eastern Time Zone

Management will hold a conference call to review the Company’s first quarter 2024 performance starting at 4:30 p.m. (Eastern Time) on the same day.

Key Points: 
  • Management will hold a conference call to review the Company’s first quarter 2024 performance starting at 4:30 p.m. (Eastern Time) on the same day.
  • The conference call will be concurrently webcast.
  • The link to the webcast will be available on Senseonics Holdings, Inc. website at www.senseonics.com by navigating to “Investor Relations,” and then “Events & Publications,” and will be archived there for future reference.
  • To listen to the conference call, please dial 1-888-317-6003 (US/Canada) or 1-412-317-6061 (International), passcode 7182212, approximately ten to five minutes prior to start time.

Baxter Reports First-Quarter 2024 Results

Retrieved on: 
Thursday, May 2, 2024
Medical Supplies, Medical Devices, Health, Pharmaceutical, Optical, Biotechnology, Sale, FDA, Baxter, Pharmacist, Sodium chloride, Food, Growth, LVP, SYR, Novum, Baxter International, Nursing, Patient, EPS, CDT, BPS, GAAP, Food and Drug Administration, Vasopressin

Baxter International Inc. (NYSE:BAX), a global medtech leader, today reported results for the first quarter of 2024.

Key Points: 
  • Baxter International Inc. (NYSE:BAX), a global medtech leader, today reported results for the first quarter of 2024.
  • Regardless of the selected path, Baxter currently expects the separation of its Kidney Care business to take place in the second half of 2024.
  • For full-year 2024: Baxter now expects sales growth of approximately 2% on a reported basis and 2% to 3% on a constant currency basis.
  • A webcast of Baxter’s first-quarter 2024 conference call for investors can be accessed live from a link in the Investor Relations section of the company’s website at www.baxter.com beginning at 7:30 a.m. CDT on May 2, 2024.

Magnus Medical Announces Commercial Launch of Groundbreaking SAINT Neuromodulation System

Retrieved on: 
Tuesday, April 30, 2024
Mental Health, Health, FDA, Medical Devices, Neurology, Health Technology, General Health, SAINT, University, CMS, DSM-IV codes, MUSC, American Medical Association, Medicine, Depression, Psychiatry, Patient, CPT, NTAP, Medicare, MRI, CSO, Magnetic resonance imaging, Multimedia, MDD, TMS, Pharmaceutical industry

Magnus Medical, Inc., a pioneering therapeutic neuromodulation company transforming the treatment of neuropsychiatric disorders, today announced the commercial launch of the SAINT® neuromodulation system, a groundbreaking, rapid-acting therapy for treatment-resistant major depressive disorder (MDD).

Key Points: 
  • Magnus Medical, Inc., a pioneering therapeutic neuromodulation company transforming the treatment of neuropsychiatric disorders, today announced the commercial launch of the SAINT® neuromodulation system, a groundbreaking, rapid-acting therapy for treatment-resistant major depressive disorder (MDD).
  • View the full release here: https://www.businesswire.com/news/home/20240430113478/en/
    The commercially available SAINT® neuromodulation system from Magnus Medical provides a new form of individualized neurostimulation therapy for treatment-resistant major depression in adults who have failed to achieve satisfactory improvement from prior antidepressant medications.
  • The American Medical Association (AMA) issued new Category III Current Procedural Terminology (CPT) codes for targeted, accelerated iTBS for depression, encompassing the SAINT neuromodulation system, effective July 1, 2024.
  • Magnus Medical expects to have selective insurance coverage in both the hospital inpatient and outpatient setting and the physician’s office.

Heidelberg Engineering Showcases the Future of Imaging, Extending Its Capabilities With a Breadth of Research Technology

Retrieved on: 
Tuesday, April 30, 2024
Technology, Biotechnology, Health, Apps, Applications, Surgery, Optical, Artificial Intelligence, Research, Medical Devices, General Health, Health Technology, Science, Data Management, Clinical Trials, FDA, University, IOL, DICOM, AI, Bausch & Lomb, Biostatistics, Artificial intelligence, 3D, SRT, OCT, Algorithm, Epithelium, Corneal topography, Google Images, ARVO, ETM, Tomography, Medical imaging

For the first time, Heidelberg Engineering will demonstrate the future of digital imaging with its investigational SEELUMA, developed and manufactured by Heidelberg Engineering subsidiary, Munich Surgical Imaging and distributed exclusively by Bausch + Lomb.

Key Points: 
  • For the first time, Heidelberg Engineering will demonstrate the future of digital imaging with its investigational SEELUMA, developed and manufactured by Heidelberg Engineering subsidiary, Munich Surgical Imaging and distributed exclusively by Bausch + Lomb.
  • The groundbreaking, fully digital, surgical-visualization platform features next-generation image technology with state-of-the-art intraoperative OCT that will transform the modern OR.
  • "In 2025, Heidelberg Engineering is set to revolutionize basic vision science with the introduction of the Heidelberg CHAMELEON Imaging Research Platform," said Heidelberg Engineering Clinical Development Manager — Investigational Technologies, Dr. Sebastian Rausch.
  • Monday night, Heidelberg Engineering will host an award presentation for the winner of the Heidelberg Engineering Xtreme Research Award that recognizes aspiring researchers for their outstanding contribution to ophthalmic research.