Philips today announced a final agreement on a consent decree with the FDA and U.S. Dept. of Justice (DOJ). The consent decree primarily focuses on its Philips’ Pennsylvania-based Respironics business — the subject of a major recall over the past several years. That includes manufacturing facilities in Murrysville and New Kensington, a service center in […]
Legal News
FTC wants more info on Boston Scientific, Axonics deal with closing timeline pushed back
Boston Scientific said today that the FTC requested additional information regarding its planned $3.7 billion acquisition of Axonics (Nasdaq:AXNX). In an SEC filing, Boston Scientific said both it and Axonics received requests from the FTC (U.S. Federal Trade Commission). The agency seeks to gather more information in connection with its review of the merger. Reports […]
Titan Medical settles dispute with contract manufacturer
Titan Medical announced today that it entered into a settlement agreement after a dispute with an unnamed contract manufacturer. Toronto-based Titan agreed to pay the contractor $2 million to settle the dispute, according to a news release. Its final payment installment is set to be made on or before June 24, 2024. Upon the receipt […]
AngioDynamics settles patent litigations with BD’s Bard
AngioDynamics entered into a settlement agreement with BD to resolve all patent litigations with Bard. Under terms of the agreement, BD will grant a license to AngioDynamics under certain of BD’s port patents. AngioDynamics will grant BD a license under certain of AngioDynamics’ catheter payments. AngioDynamics will also make a one-time payment of $7 million, […]
Neuralink may be getting some scrutiny on Capitol Hill
Reuters reports that U.S. Rep. Earl Blumenauer (D-OR) issued a letter to the FDA questioning its inspection practices related to Neuralink. The report said Blumenauer asked why the FDA decided not to investigate the Elon Musk-backed brain chip maker before allowing in-human trials. This relates to repeated questions around animal practices at the company. Reuters […]
FDA wants to ban electrical stimulation devices for self-injurious, aggressive behavior
In a rare move, the FDA is taking steps to ban electrical stimulation devices (ESDs) for self-injurious or aggressive behaviors. Owen Faris, acting director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health, announced the proposal this week, marking the second attempt by the agency to […]
PTAB upholds two Medtronic patents in spat with Axonics, could go to jury trial
Medtronic announced today that the U.S. Patent and Trademark Office upheld many of its claims around two of its patents in its battle with Axonics (Nasdaq:AXNX). The office’s Patent Trial and Appeal Board (PTAB) affirmed the validity of many of the claims in two of Medtronic’s patents in the latest development in a long-running spat […]
Former Stimwave CEO convicted of healthcare fraud
The U.S. Justice Dept. announced last week that a jury found former Stimwave CEO Laura Perryman guilty of healthcare fraud. Damian Williams, U.S. Attorney for the Southern District of New York, last week announced the jury’s verdict. It found Perryman guilty on two counts of an indictment charging her with conspiracy to commit healthcare fraud and […]
FTC reportedly may scrutinize Boston Scientific’s Axonics deal
Bloomberg reports that the U.S. Federal Trade Commission (FTC) may look into the $3.7 billion acquisition of Axonics (Nasdaq:AXNX) by Boston Scientific . A new Axonics regulatory filing with the SEC discloses that the companies refiled their Hart Scott Rodino (HSR) Act notification to the FTC on March 4 — a move that companies sometimes […]
Medtronic may face jury trial in spine implants case
A nearly decade-old whistleblower suit against Medtronic — involving FDA clearance of spine fusion devices — is moving forward. In an order dated Feb. 16, U.S. District Court Judge John Kronstadt in Central California denied Medtronic’s motion for summary judgment in the case filed by The Dan Abrams Co. LLC. The LLC’s sole employee, Bryan […]
Medtronic asks ITC to stop Axonics’ sales of neuromod devices
Medtronic today announced that it filed a complaint to the U.S. International Trade Commission (ITC) to block the sales of certain Axonics (Nasdaq:AXNX) devices. The complaint to the ITC runs parallel to action in the U.S. District Court for the District of Delaware. Medtronic wants to block Axonics from “improperly importing and selling products that infringe […]