TELA Bio Launches OviTex Inguinal Reinforced Tissue Matrix in Europe
TELA Bio, Inc. announced on June 3, 2025, the launch of its OviTex Inguinal Reinforced Tissue Matrix in Europe. TELA Bio—which was founded in 2012 and is headquartered in Pennsylvania—is...
European Union Votes to Curb China’s Access to Medical Device Market
The European Union has “agreed overwhelmingly” to limit Chinese medical device manufacturers’ access to public procurement contracts in Europe, Bloomberg reports. On Monday June 2, 2025, European Union (EU) countries reportedly voted to ban...
Bipartisan Law Introduced to Clarify Patent Eligibility
For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries...
FDA Accuses Third Party Testing Labs of Falsifying Data
The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...
How New U.S. Tariffs Could Reshape Patent Litigation in the Medical Device Industry
As the U.S. imposes sweeping new tariffs on over 180 countries and territories—including a baseline 10% rate and steep increases for China (originally 145%, now reduced to 30% for 90...
Medtech Leaders Speak Out On Impact of Global Tariffs
Some Medtech companies recently addressed the potential impact of global tariffs in their Q1 2025 earnings calls. Johnson & Johnson and Abbott were among the first to speak on the implications...
U.S. Tariffs and the Medical Device Industry
As of April 24, 2025, the United States has imposed tariffs on over 180 countries and territories. This includes a universal 10% baseline tariff while larger tariffs are in a...
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.
