An Alternative for Treating Mitral Regurgitation Receives Support for Ongoing Trial
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...
Zydus Lifesciences in Discussions to Acquire Majority Stake in Amplitude Surgical for €256.8m ($277.4m)
Zydus Lifesciences Limited announced on March 11, 2025, that it entered into an agreement to acquire a majority stake in Amplitude Surgical. Reports state that Zydus Lifesciences has a tender offer agreement with PAI Partners,...
Boston Scientific Agrees to Acquire Sonivie Ltd. For up to $540 Million
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 Ultrasound System. SoniVie...
Global Market Size and Technological Advancements for Implantable Medical Devices Continue to Grow
A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The rapid increase...
Zimmer Biomet to Acquire Paragon 28
Zimmer Biomet recently announced entering a definitive agreement to acquire all outstanding common shares of Paragon 28. Under the agreement, Zimmer Biomet will pay $13.00 per share, valuing Paragon 28 at approximately $1.1 billion....
Stryker to Spin off Spinal Implants Business
Stryker, one of the world’s largest medtech companies, announced on January 28 that it would be selling its Spinal Implants business to Viscogliosi Brothers, a New York-based, family-owned investment firm founded...
FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development
The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product...
Stryker Acquires Inari Medical for $4.9 Billion
Stryker Corporation (“Stryker”) recently announced that it has entered into a definitive agreement to acquire Inari Medical, Inc. (“Inari”) for approximately $4.9 billion. Inari develops technologies and products for treating pulmonary embolism, deep vein thrombosis, in-stent...
Edwards v. Meril at the Supreme Court: Testing the Scope of Hatch-Waxman’s Safe Harbor
On October 11, 2024, Edwards[1] filed a petition for a writ of certiorari with the U.S. Supreme Court.[2] The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe...
Medical Device Deal Activity Shows Signs of Life for Q3 2024
Market reports indicate the global medical device industry for Q3 2024 saw an increase in merger and acquisition (M&A) activity in terms of value year-over-year. Although deal value decreased compared to...
Teva v. Amneal Oral Arguments and Claim Construction Order: Recent Developments in the Ongoing Debate Over the Orange Book Listing of Device Patents
As the FTC continues to crack down on pharmaceutical manufacturers’ allegedly improper listing of patents in the FDA Orange Book, counsel for Teva and Amneal presented oral arguments in the Court of Appeals for the Federal Circuit on November 8,...
Novacure’s Wearable Lung Cancer Treatment Device, Optune Lua, Receives FDA Approval
The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to treat advanced non-small cell lung cancer (NSCLC). The device utilizes portable transducer arrays placed on the skin to deliver alternating electrical fields, termed Tumor Treating Fields (TTFs), thereby disrupting malignant cell division while leaving healthy cells largely unaffected.
Women’s Health Medical Device Company Caldera Medical Acquires UVision 360
Caldera Medical, Inc. on October 8th, 2024, announced the acquisition of UVision 360, Inc. Caldera Medical develops medical devices for women’s health, including surgical products for the treatment of stress urinary incontinence, pelvic floor disorders, pelvic organ prolapse, and hysteroscopic removal of intrauterine tissue. UVision 360 is a developer of in-office hysteroscopy systems for evaluating and treating uterine conditions.
Vertos Medical Latest Acquistion in Stryker’s M&A Streak
Medical technologies giant Stryker announced on Tuesday, October 1st, that it completed the acquisition of Vertos Medical for an undisclosed amount. Vertos Medical is a privately held company specializing in interventional pain management solutions for chronic back pain caused by lumbar spinal stenosis.
Cook Medical Sells Lead Management Portfolio to Merit Medical
Cook Medical recently announced it is selling its lead management portfolio to Merit Medical. Cook Medical is a medical device manufacturer with a portfolio of products used in lead management procedures, including for patients who need a pacemaker or an implantable cardioverter-defibrillator lead removed or replaced. Merit Medical is a manufacturer of disposable medical devices and has products used in interventional, diagnostic, and therapeutic procedures, including in the fields of cardiology, critical care, endoscopy, oncology, and radiology.
Test Anxiety: FDA Issues Warning Letters to Test Laboratories
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns with the quality and integrity of data generated.” The press release can be found here.
Getinge Acquires Paragonix Technologies
Getinge, a Swedish public limited company, announced on September 11, 2024 that it completed acquisition of Paragonix Technologies, Inc., a U.S. company specializing in organ transport products and services. According to Getinge’s press release, the total purchase price was $477 million.
ARPA-H Announces New Funding related to AI-Enabled Medical Tools
The U.S. Advanced Research Projects Agency for Health (ARPA-H) announced new funding for a “program to help AI-enabled medical tools maintain peak performance.” The new funding is through the Performance and Reliability Evaluation for Continuous Modifications and Usability of Artificial Intelligence (PRECISE-AI) program.
Parent (Un)Trap: Most Parent Patents Cannot Be Invalidated by Their Children Because of PTA
Medical device companies are often well versed in prosecuting multiple patents within a single “family.” Indeed, such families are often of significant value to early stage (and later stage) medical device companies. But a Federal Circuit decision from last year raised the possibility that the continued prosecution of patents within a family could invalidate those early, valuable patents. In a clarifying decision, the Federal Circuit recently explained that “a first-filed, first-issued, later-expiring claim (e.g., in a Parent Patent) cannot be invalidated (under the doctrine of obviousness-type double patenting – “ODP”) by a later-filed, later-issued, earlier-expiring reference claim (e.g., in a child patent) having a common priority date.” This may sound complicated, but it can be good news for patent owners who own a family of patents because it is now less likely that a later prosecution will invalidate an earlier issued patent.
GE Healthcare Announces Deals in AI
GE HealthCare on July 25th, 2024, announced a collaboration with Amazon Web Services (AWS) to develop purpose-built foundation models and generative artificial intelligence (AI) applications. According to the GE HealthCare press release, the company intends to utilize Amazon Bedrock to amplify the advantages of generative AI for their customers and build its own proprietary generative AI applications for healthcare use cases.
Dr. Jeff Shuren, FDA CDRH Director, to Retire
On July 23, 2024, Dr. Jeff Shuren, the director for the Center for Devices and Radiological Health (CDRH), announced that he will retire. Dr. Shuren became director of the CDRH in 2009. As director of the CDRH, Dr. Shuren oversaw the approval of medical devices and monitoring of radiation-emitting products.