Enforcement & Litigation
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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