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Senate report faults hospitals, device makers, FDA for deadly ‘superbug’...
A report by Democrats on the U.S. Senate’s health committee issued this week blames hospitals, medical device companies and the FDA for the deadly outbreaks of so-called “superbug” infections linked to...
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Update: PE shop Aurora Capital buys Cardiac Science
Update: Added legal information on the bankruptcy sale Private equity firm Aurora Capital Group said today it acquired the assets of Cardiac Science in a court-approved sale. The buy was approved by...
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Cyber attacks on industrial control systems mount
(Reuters) — A U.S. government cybersecurity official warned that authorities have seen an increase in attacks that penetrate industrial control system networks over the past year, and said they are...
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Uptake Medical launches InterVapor lung device
Uptake Medical said today it launched a registry trial of its InterVapor system to investigate long-term clinical results in severe emphysema patients. The InterVapor uses heated water vapor to reduce...
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Boston Scientific CMO Dawkins: Rivals spent $1.5B on 80 patients and half are...
Medical device acquirers spent something in the neighborhood of $1.5 billion over the past few months on transcatheter mitral valve replacement acquisitions to treat just 80 patients, half of whom are...
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MiMedx picks up regenerative focused Stability Biologics
MiMedx (NSDQ:MDXG) said it completed its acquisition of human tissue product provider Stability Biologics, paying $10 million at closing and saying it expected the buy to be accretive to its full year...
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MassDevice.com +3 | The top 3 medtech stories for January 14, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the...
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Philips launches mobile obstetrics monitor in Indonesia
Royal Philips (NYSE:PHG) said today it inked a deal with West Sumatra, Indonesia-based Sijunjung Regency to launch its Mobile Obstetrics Monitoring service in the region. The service is designed to...
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Lantheus sells Canadian radiopharmacy biz for $9m
Lantheus Medical Imaging said yesterday it sold its radiopharmacy and Canadian Gludef manufacturing and distribution businesses to Isologic Radiopharmaceuticals for $9m. As part of the sale, Lantheus...
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Two startups win seed funding for pediatric med devices
The Philadelphia Pediatric Medical Device Consortium said today it issued 2 seed grants of $50,000 each to 2 medical device companies focused on pediatric care. The 1st is Bellefonte, Penn.-based...
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Conavi wins 510(k) for cardiac ultrasound imager
Conavi medical said today it won FDA 510(k) clearance for its Foresight ICE System designed for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy. The device...
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Imricor wins CE Mark for MR-conditional recording system
Imricor Medical Systems said today it won CE Mark approval in the European Union for its Advantage-MR EP recorder/stimulator system, designed to allow for MRI-guided electrophysiology procedures. The...
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ANVISA reports improved timeframes for some medical device market applications
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulators have reduced timeframes in 2015 for responding to and processing submissions from registrants, according to an Emergo...
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Boston Scientific smuggled counterfeit resin for pelvic mesh, racketeering...
A purported class-action racketeering lawsuit filed this week accused Boston Scientific (NYSE:BSX) of illegally smuggling counterfeit resin made in China to make pelvic mesh, after its original...
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AngioDynamics must face Bard patent infringement lawsuit
AngioDynamics (NSDQ:ANGO) must face a patent infringement lawsuit brought by Bard and subsidiary Bard Peripheral Vascular, a federal judge in Delaware ruled this week. Murray Hill, N.J.-based Bard sued...
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Edwards Lifesciences wins FDA nod for new Sapien 3 trial
Edwards Lifesciences (NYSE:EW) said today that the FDA approved a new trial of its Sapien 3 replacement heart valve. The Sapien 3 transcatheter aortic valve replacement was approved last year by the...
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VertiFlex drums up $27m for spinal implants
VertiFlex reported raised nearly $27 million in an equity and options offering this month, according to a regulatory filing. San Clemente, Calif.-based VertiFlex, which won pre-market approval from the...
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UPDATE – Preventing superbugs: FDA clears redesigned Olympus endoscope
Updated to include information from Olympus. The FDA today said it cleared a redesigned version of Olympus‘ (TYO:7733) TJF-Q180V duodenoscope, with modifications intended to reduce the risk of...
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FDA: Brainlab Cranial IGS system recall is Class I
The FDA today labeled a recall of Brainlab’s Cranial image-guided surgery system as a Class I recall over issues with potential inaccuracies in the navigation display. The federal watchdog labeled the...
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Bioventus taps ex-Medtronic CEO Hawkins for chairman | Personnel Moves
Bioventus said it tapped former Medtronic (NYSE:MDT) and Immucor (NSDQ:BLUD) chief Bill Hawkins to be its new chairman, replacing Dan LeMaitre. Hawkins, who’s slated to appear at the upcoming...
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