News & Analysis as of

Health Technology Life Sciences Medical Devices

Knobbe Martens

TELA Bio Launches OviTex Inguinal Reinforced Tissue Matrix in Europe

Knobbe Martens on

TELA Bio—which was founded in 2012 and is headquartered in Pennsylvania—is a medical device company that specializes in providing soft-tissue surgical products. According to TELA Bio, its soft-tissue reconstruction solutions...more

Benesch

Dialysis & Nephrology Digest - June 2025

Benesch on

Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney...

Maynard Nexsen on

In this powerful episode, hosts Heather and Matthew are joined by Sydney Severance, a young woman and former competitive athlete whose life changed dramatically when she unexpectedly became wheelchair-bound. After a...more

Knobbe Martens

An Alternative for Treating Mitral Regurgitation Receives Support for Ongoing Trial

Knobbe Martens on

Mitral regurgitation is the most common form of valvular heart disease and affects around 10% of Americans over 75. It occurs when the mitral valve, which is located between the left atrium and the left ventricle, doesn’t...more

Knobbe Martens

Boston Scientific Agrees to Acquire Sonivie Ltd. For up to $540 Million

Knobbe Martens on

Boston Scientific recently announced it entered into a definitive agreement to acquire SoniVie Ltd. According to the press release, SoniVie is a privately held medical device company that developed the TIVUS Intravascular...more

Husch Blackwell LLP

Raising Capital in a Highly Regulated Market

Husch Blackwell LLP on

For early-stage life sciences and health tech companies, raising capital is about more than demonstrating scientific promise. Investors are increasingly focused on regulatory preparedness, reimbursement strategy, and risk...more

Benesch

Dialysis & Nephrology Digest - February 2025

Benesch on

A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

A&O Shearman on

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

Morgan Lewis

Healthcare and Life Sciences: Key Insights and Considerations for Stakeholders in 2025

Morgan Lewis on

This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more

Jones Day

Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices

Jones Day on

The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Lauren are joined by Mattney Beck of Lenovo, a well-known multinational technology company, to discuss their innovations in XR or Extended Reality...more

Troutman Pepper Locke

AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast

Troutman Pepper Locke on

Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett Mason is joined by Partner Eric Rumanek and...more

Foley & Lardner LLP

HSBC Venture Healthcare Report: 1H 2024

Foley & Lardner LLP on

For a succinct analysis of 1H 2024 venture investment and exit activity in life sciences and health care, take a look at HSBC’s Venture Healthcare Report, Shake it off: HSBC Innovation Banking Analysis, 1H 2024. Lead author...more

Knobbe Martens

Florida Man Makes Medical Device – A Survey of MedTech in the Sunshine State

Knobbe Martens on

Florida is more than just the home of alligators and presidential candidates. The state was recently ranked as the fourth largest “medical device state” in the U.S., after California, Minnesota, and Massachusetts.  It was...more

Wilson Sonsini Goodrich & Rosati

[Event] Medical Device Digital Health Conference - June 13th - 14th, San Francisco, CA

Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more

Arnall Golden Gregory LLP

Welcome to the Machine: FDA Issues White Paper on AI and Medical Products

For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more

Knobbe Martens

3M Spins Off Healthcare Business Solventum

Knobbe Martens on

3M recently completed the spinoff of its healthcare technology business as the new standalone public company, Solventum Corporation.  Solventum has an IP portfolio with over 7,300 patents globally....more

McDermott Will & Emery

FDA Clears First OTC Continuous Glucose Monitor

McDermott Will & Emery on

On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM...more

Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more

Faegre Drinker Biddle & Reath LLP

Life Sciences AI Summit: Industry Leaders Highlight Key Opportunities and Urge Caution as AI’s Prominence Grows

The American Conference Institute hosted its inaugural Life Sciences AI Summit in New York on February 21 and 22. The two-day conference brought together key stakeholders, including regulatory players such as FDA and the...more

BCLP

Lessons From the Growth of Femtech and Women’s Health

BCLP on

BCLP’s Healthcare & Life Sciences Practice Group recently partnered with EMIG Digital Health Group to co-host an in-person breakfast seminar and networking event focused on FemTech. Specialists from across the FemTech and...more

Alston & Bird

Health Care Week in Review: Biden Administration Issued Final Rule on Fees for IDR Process Under NSA; W&M Democrats Release Report...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more

McGuireWoods LLP

Health + Tech - Improving Cancer Care With Digital Health Tools

McGuireWoods LLP on

Jessica Thurmond and Monica Schmiede, co-CEOs and co-founders of Athelo Health — the first biometric-anchored virtual coach for women with breast and gynecologic cancers — join McGuireWoods partner Kristen McDermott Woodrum...more

Axinn, Veltrop & Harkrider LLP

FDA Tackles AI . . . and Other Digital Health Technologies

FDA announced on October 11, 2023 that it is creating a new Digital Health Advisory Committee to provide guidance to FDA on issues relating to digital health technologies ("DHTs"), including artificial intelligence,...more

46 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide