Approvals


Newborn Screening Tests Among FDA Classifications

 
• By 

The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Medtronic Announces Collaboration To Create A ‘New Era’ in Surgical Training

 

Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

Compliance


Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By 

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By 

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By 

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.

DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

 
• By 

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.

Recalls


Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

Serious Injuries Tied To Medtronic Bravo GERD Diagnosing System

 

The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

Regulation


EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 

MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.

New Regulation Significantly Expands eIFU Usage Scope

 

Amendment brings new benefits for device accessories and aesthetic devices used by healthcare professionals.

New EU Rules Limit Chinese Participation In Medtech Procurement

 

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

Legal & IP


Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By 

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

 
• By 

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

 
• By 

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.

Legislation


Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

Industry Execs Talk Tariff Turbulence During MD&M East

 

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By 

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By 

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.