Medtronic to Acquire SPR Therapeutics for $650 Million
(May 20, 2026) 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...
Johnson & Johnson to Acquire Atraverse Medical
May 8, 2026 | Matt Whitehead Johnson & Johnson (J&J) reported on April 24, 2026, that it has entered into an agreement to acquire Atraverse Medical, a company in the...
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...
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...
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...
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...
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...
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...
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...
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...
