Royal Philips (NYSE:PHG) issued a medical device correction in Europe last month to warn users of internal damage suffered by its HeartStart MRx monitor/defibrillators. The Amsterdam-based company said in the notice that it received reports of HeartStart MRx devices that suffered internal damage and could not deliver therapy after they were dropped or subjected to a […]
Judge tosses wrongful termination suit against Abiomed
Abiomed (NSDQ:ABMD) has convinced a federal judge that whistleblower Max Bennett had no basis on which to claim the company fired him in retaliation for his investigation of federal False Claims Act violations. Judge Indira Talwani ruled on Tuesday that “no reasonable jury could find that Bennett had engaged in protected activity or that he was […]
Bardy Diagnostics’ patch could monitor coronavirus patients prescribed HCQ experimentally
Bardy Diagnostics says Seattle-area health providers are using its Carnation ambulatory monitor (CAM) patch to measure QT segments in COVID-19 patients prescribed hydroxychloroquine (HCQ) experimentally. Hospitals across the city in their protocals have slated the local company’s CAM patch for use monitoring cardiac rhythms after coronavirus patients on HCQ are discharged from the hospital, as […]
How is the coronavirus affecting medtech events?
The coronavirus (COVID-19) outbreak has swept the globe and made a huge impact in the medtech space — especially when it comes to the events that provide a crucial networking and innovation-sharing function. The March 5 cancellation of the Healthcare Information and Management Systems Society (HIMSS) 2020 Global Health Conference & Exhibition was one of […]
FDA allows use of AliveCor’s Kardia device for COVID-19 patients
AliveCor announced that the FDA now allows the company’s KardiaMobile 6L electrocardiogram (ECG) for use in measuring QTc (a heart rhythm disorder that can potentially cause fast, chaotic heartbeats) in patients with COVID-19. The Mountain View, Calif.-based company touts its KardiaMobile 6L as the world’s only six-lead personal ECG. It is designed to detect potentially […]
5 companies on the front lines of the coronavirus fight
Nancy Crotti, Managing Editor and Danielle Kirsh, Senior Editor Amid the stock market roller-coaster ride that began last month, medtech companies that make devices and diagnostic tests vital to fighting COVID-19 may ultimately fare better than others, but it’s hard to tell until the virus peaks and people get back to work. At midafternoon today, […]
CMS recommends postponing most elective procedures
The Centers for Medicare and Medicaid Services (CMS) released guidance late yesterday asking healthcare providers to postpone adult elective surgeries and procedures, including dental procedures, until further notice. The move is an attempt to preserve the supply of ventilators and personal protective equipment such as masks and gowns while protecting patients and staff from exposure […]
Endologix wins FDA approval for abdominal stent graft system
Endologix today said it received FDA approval for its Alto Abdominal Stent Graft System. The company said it received approval based on its regulatory submission that included results from its Elevate Investigational Device Exemption clinical study. Under the terms of the FDA approval, the first 100 patients after commercial launch will be included in a […]
U.K. court bars Edwards TMVR sales, gives Abbott win in patent spat
A judge in the England issued an injunction yesterday barring Edwards Lifesciences from selling its Pascal transcatheter mitral valve repair (TMVR) device in the U.K. A different judge had previously denied Abbott’s petition for such an injunction. Yesterday, Judge Colin Birss of the High Court of England and Wales also ruled that two patents held […]
Impulse Dynamics appoints medical director
Cardiac contractility modulation (CCM) therapy developer Impulse Dynamics announced that it is appointing Dr. Ishu Rao as its medical director. Rao previously spent 17 years in a clinical practice treating heart failure patients, with a focus on interventional therapies, according to a news release. He received his cardiology training at Harbor-UCLA Medical Center in Torrance, […]
Medtronic recall of HeartWare HVAD system battery charger is Class I
The FDA has labeled a Medtronic (NYSE:MDT) HeartWare HVAD system battery charger as Class I — it’s most serious level. A notice out March 9 from the FDA said that the Fridley, Minn.-based medtech giant recalled 5,489 total battery charger devices due to the potential for an HVAD system user to mistakenly insert the charger’s AC […]
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