Abiomed, a Johnson & Johnson unit, has received an FDA warning letter related to its Class I recall of Impella heart pumps. The agency wrote Abiomed up for failing to report problems with the heart pump and selling its Impella Connect System software and hardware without FDA authorization. The FDA issued the letter in September after inspecting […]
Johnson & Johnson drops 136-year old logo and renames Janssen
Johnson & Johnson has rebranded with a new logo and a new name for its Janssen pharmaceutical business one year after renaming its medical device business — and just weeks after spinning off its consumer health business. New Brunswick, New Jersey–based Johnson & Johnson (NYSE: JNJ) has replaced its 136-year-old logo — based on the signature […]
Abbott recalls neurostimulation implants for Bluetooth bricking flaw
Abbott has recalled more than 155,000 implantable pulse generators (IPGs) due to a Bluetooth connectivity flaw that has left some devices unusable. The Class I recall — the FDA’s most serious level — covers Proclaim and Infinity IPGs used for three kinds of neurostimulation: Spinal cord stimulation: Proclaim XR 5 IPG Model 3660 (previously known […]
FDA review panel: Medtronic Symplicity Spyral RDN risks outweigh benefits
An FDA review panel voted against recommending approval of Medtronic’s Symplicity Spyral renal denervation (RDN) therapy for hypertension under the proposed indications. The panel unanimously said the minimally invasive catheter system is safe, but was nearly split on efficacy. With six members voting that the benefits outweighed the risk, six voting the other way and […]
ResMed shares near 52-week low after disappointing results
ResMed shares are down on fourth-quarter sales and profits that missed Wall Street’s expectations. The device manufacturer’s stock was trading around $183.58 per share near noon, approaching the 52-week low of $181.50. The stock hasn’t closed below $188 since April 2021, when competitor Philips initiated a recall of millions of continuous positive airway pressure (CPAP) […]
Steris reports strong Q1 on big gains in healthcare
Steris today reported first-quarter results that exceeded Wall Street’s expectations while upping guidance for the year ahead due to a recently announced acquisition. The Dublin, Ireland-based provider of sterilization services and other infection prevention tech posted profits of $123.6 million in the quarter ended June 30, 2023. That amounts to $1.25 per share on sales […]
Boston Scientific plans $170M ‘Project Black Bear’ expansion
Boston Scientific is planning an expansion outside Minneapolis for a new divisional headquarters campus. The Marlborough, Massachusetts-based medical device manufacturer is working on the $170 million expansion with the Minneapolis suburb of Maple Grove and the Minnesota Department of Employment and Economic Development (DEED). The project’s backers were using the code name “Black Bear” as […]
Masimo loses board seats to activist investor Politan
Masimo shareholders voted to oust two members of the device developer’s board after a heated battle by activist investor Politan Capital Management. Masimo has yet to release official results, but acknowledged defeat today in a statement to MassDevice. “We are disappointed to have lost the valuable contributions of two very qualified and capable board members,” […]
ISS backs Politan’s nominees in Masimo board battle; Device developer says CEO is the target
Politan Capital Management’s fight for two Masimo board seats won a key endorsement from proxy advisory firm Institutional Shareholder Services (ISS), the activist investor said today. ISS is recommending Masimo shareholders vote for Politan’s two board nominees: Politan Managing Partner and Chief Investment Officer Quentin Koffey and former Johnson & Johnson MedTech executive Michelle Brennan. […]
iRhythm’s FDA warning letter details alleged violations and patient deaths
An FDA warning letter made public today accused iRhythm Technologies of violations of the Federal Food, Drug, and Cosmetic Act’s rules for labeling, quality systems and medical device reporting. In at least two cases, iRhythm did not report patient deaths in the required 30-day window, and instead reported them the following year, the FDA said. […]
Masimo makes an offer in board election fight with Politan
Masimo today promised to accept one of the board members proposed by Politan Capital Management under certain conditions while taking more shots at the activist investor’s leader. The device developer said it would appoint former Johnson & Johnson MedTech executive Michelle Brennan to the board if shareholders voted to expand it from five members to […]