FDA to Hold Public Meeting on Proposed Medical Device Review Recommendations
Key Takeaway: The FDA announced a public meeting and request for comments on proposed Medical Device User Fee Amendments (MDUFA )recommendations for fiscal years 2028-2032, which would govern medical device...
FDA to Drop 510(k) Requirements for Certain Low-Risk Devices, Lowering Barriers to Entry
On June 5, 2026, the U.S. Food and Drug Administration (FDA) issued updated guidance stating its intent to exempt certain unclassified medical devices from premarket 510(k) requirements, and that the FDA believes the identified device...
Epineuron Receives 510(k) Clearance for Nerve Stimulator
Epineuron Technologies, a Canada-based clinical-stage nerve care company developing a bioelectronic therapy for the treatment of injured peripheral nerves, announced on May 12 that it has received 510(k) clearance of its Evala® Nerve Stimulator from the...
Medtronic to Acquire Spr Therapeutics for $650 Million
Medtronic announced its plans to acquire SPR Therapeutics, a privately held medical device company that specializes in non-opioid, non-surgical, and minimally invasive solutions for acute and chronic pain. The transaction is valued at...
Johnson & Johnson to Acquire Atraverse Medical
Johnson & Johnson (J&J) reported on April 24, 2026, that it has entered into an agreement to acquire Atraverse Medical, a company in the cardiovascular medical device sector, for an undisclosed amount. The deal...
Drummond Scientific Expands MedTech Operations with Accu-Glass Acquisition
Recently, Drummond Scientific Company announced its acquisition of Accu-Glass. Drummond, headquartered near Philadelphia, has more than 75 years of experience in precision manufacturing for the life sciences and medical technology industries, including the manufacture of medical...
FDA Emphasizes Use of Real-World Evidence for Medical Device Makers
The U.S. Food and Drug Administration (FDA) has increasingly emphasized the use of real-world evidence (RWE) to support regulatory decision-making for medical devices. As medical technologies evolve and data sources...
FDA Announces “RAPID” Pathway for Expedited Access to Breakthrough Devices by Medicare Population
On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced “a new pathway designed to expedite access to certain FDA-designated Class II...
Protaryx Receives FDA Approval for Transseptal Puncture Device
Protaryx Medical, a Maryland-based company dedicated to “minimally invasive left-heart interventional therapies,” announced that its Transseptal Puncture Device received 510(k) clearance from the FDA. Transseptal puncture is designed to enable access to...
Stryker Provides Update After Cyberattack
According to a press release, Stryker Corporation recently “experienced a cybersecurity attack which resulted in a global disruption to Stryker’s (internal, corporate) Microsoft environment.” A cyberterrorist organization, Handala, reportedly claimed responsibility...
U.S. Considering Tariffs on Med Device Imports; Trade Groups Push Back
The Commerce Department is investigating whether imports of personal protective equipment (PPE), medical consumables, and medical devices and equipment have national security implications that may warrant trade action, such as...
Abbott to Expand Its Cancer Diagnostic Segment
Abbott recently announced that it agreed to acquire Exact Sciences for approximately $21 billion to enter the fast-growing cancer diagnostic segment. Under the terms of the agreement, Abbott will acquire all outstanding shares of...
How to Measure Performance for AI-Enabled Medical Devices? FDA Seeks Public Input
On September 30, 2025, the U.S. Food and Drug Administration (FDA ) posted a Request for Public Comment regarding how to measure the performance of medical devices enabled with artificial intelligence (AI). The...
The FDA Drops New Laboratory Test Regulations
Laboratory-developed tests (“LDTs”) are in vitro diagnostic (“IVDs”) products designed and used within a single clinical laboratory to perform high complexity testing. These tests can identify a wide range of issues...
Keeping Up With AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-Enabled Devices
On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions) to provide recommendations...
Application of Safe Harbor Exceptions to the Anti-Kickback Statute
On August 7, 2025, the Office of the Inspector General (“OIG”) issued Advisory Opinion 25-09 (“Advisory Opinion”) providing a favorable opinion regarding remuneration to physicians with an ownership interest in a medical device manufacturer....
Recent Machine Learning Studies in Medical Imaging Applying FDA Principles
Medical imaging is one of the most promising fields for use of AI tools, as pattern recognition and large data sets can enhance human diagnosis (e.g., by radiologists) or even compete...
Cardiosense Obtains FDA Clearance for Wearable Cardiac Sensor
Cardiovascular disease is a leading cause of death, with over 900,00 deaths reported in the United States in 2023. In this context many companies have pursued products to help diagnose...
China Responds to European Union’s Medical Device Restrictions With Restrictions of Its Own
China has imposed restrictions on procurement of European medical devices, following the European Union’s vote to limit Chinese companies from participating in public procurement tenders for medical device contracts last...
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...
