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Enforcement & Litigation

Set Alert for Enforcement and Legislation

DME Company Owner Pleads Guilty To Health Care Fraud

The woman admitted to billing US Medicare for more than $50m in equipment without legitimate physician orders.  

Legal Issues Policy Enforcement

Senate Proposes Smaller Boost Than House For FDA FY2023 Appropriation

A  proposed budget from the US Senate appropriations committee would fund the FDA's device activities at $663m for fiscal 2023, marking a modest increase from 2022 but a drop from House and administration requests. 

Policy Regulation

Medtronic Recalls Cardiac Defibrillators Due To Reduced Shock Potential

The device giant is recalling Cobalt and Crome defibrillators because they may deliver weaker shocks than intended.

Enforcement Recalls

Class I Recall For BD Intraosseous Infusion System

The US FDA has labelled a recall of Becton Dickinson intraosseous needle set kits, manual driver kits, and powered drivers as class I, its most severe designation. 

FDA Recalls

Surgalign Pays $2M To Resolve SEC Investigation

US financial regulators said that the spinal device company falsely attributed future sales to the current quarter as a way to disguise lower-than-expected sales.

Regulation Enforcement

Class I Recall For Haimen Shengbang Viral Sampling Containers

The US FDA has designated a recall of Haimen Shengbang Laboratory Equipment Co. viral transport media containers as class I, the agency’s most serious designation.

FDA Recalls

Philips In Talks With DOJ Over Breathing Machine Recalls

After being subpoenaed by the US Department of Justice in April, Philips says it is negotiating with the department on a consent decree addressing numerous recalled breathing devices made by Philips Respironics.

FDA Recalls

Eight Indicted In Alleged Genetic Testing Fraud

The eight had ties to a group of Tennessee labs that reportedly paid physicians to order medically unnecessary testing, billing Medicare more than $150m in five years.

Policy Legal Issues

Road To Modernization A Bumpy One For FDA, Says Woodcock

During a webinar hosted by the Alliance for a Stronger FDA, the US agency’s Deputy Commissioner Janet Woodcock discussed the FDA’s efforts to modernize how it collects and analyzes data.

FDA Legislation
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