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FDA releases May 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2016 TOTAL 510(k)s THIS PERIOD 213 TOTAL WITH SUMMARIES 205 TOTAL WITH STATEMENTS 8 May 2016 510(k) Clearances...
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Medtronic teases new “extravascular” ICD system
Medtronic (NYSE:MDT) today released results from feasibility studies of its new “extravascular” EV-ICD System implantable cardioverter defibrillator designed with leads placed outside the hearts and...
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FDA clears Ares robot-assisted bronchoscopy device from Auris Surgical Robotics
The FDA last month granted 510(k) clearance to the Ares robot-assisted bronchoscopy platform developed by stealthy Auris Surgical Robotics. San Carlos, Calif.-based Auris was co-founded by medical...
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Google’s Verily Star Trek “Tricorder” moonshot flops
Verily’s moonshot project which aimed to create a futuristic every-aspect diagnostic device and cancer treatment, much like Star Trek’s “Tricorder” devices, has flopped after 3 years in development,...
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FDA warns Spectranetics on Glidelight, SLS II lead extraction sheaths
The FDA sent a warning letter last month to Spectranetics (NSDQ:SPNC), flagging the company for problems with its GlideLight and SLS II lead extraction sheaths made in Colorado. The FDA inspected...
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Nevro prices $150m offering
Nevro Corp. (NYSE:NVRO) today released pricing information for a new public offering, expecting to bring in $150 million, with another $22.5 million possible through a 30-day underwriters option. The...
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Medtronic launches Valiant Evo TAA device trial
Medtronic (NYSE:MDT) said today it enrolled the 1st patient in a trial of its Valiant Evo thoracic stent graft system designed for the minimally invasive repair of descending thoracic aortic aneurysms....
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MassDevice.com +5 | The top 5 medtech stories for June 8, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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Palo Alto Advanced Life Sciences Fund raises $40m
Palo Alto Investors have raised $40 million for its newly launched Advanced Life Sciences Fund, according to a new SEC filing. The fund looks to invest in healthcare companies who have “outgrown the...
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AirXpanders raises $15m, taps medtech vet Murcray for CFO-COO role
AirXpanders (ASX:AXP) said today that it raised $14.9 million (A$20 million) for its AeroForm tissue expander and tapped medical device veteran Scott Murcray to be its CFO/COO. Palo Alto, Calif.-based...
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Sensus Healthcare closes $11m IPO
Sensus Healthcare (NSDQ:SRTSU) said today it closed its initial public offering, raising $11 million through the sale of 2.3 million units at $5.50 each. The offering included a fully-exercised...
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Philips CEO van Houten: Tech-savvy patients drive the agenda
(Reuters) – Demand from technology-savvy patients seeking control over their medical data will overcome privacy concerns about the “connected” products and services Royal Philips (NYSE:PHG) is now...
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Cantel Medical jumps on Street-beating Q3
Cantel Medical (NYSE:CMN) today released its 3rd quarter earnings for its fiscal year 2016, beating the Street across the board and seeing shares lift. The Little Falls, N.J.-based company reported...
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InspireMD lifts COO Barry to the corner office | Personnel Moves June 8, 2016
InspireMD lifts COO Barry to the corner office InspireMD (OTC:NSPR) said yesterday it promoted COO Dr. James Barry to the office of CEO and president, effectively immediately. Former CEO Alan Milinazzo...
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Boston Scientific: Headcount ‘relatively unchanged’ in restructuring, but...
Boston Scientific (NYSE:BSX) said yesterday that the next stage in the turnaround engineered by chairman & CEO Mike Mahoney will involve an unspecified number of layoffs, although its overall...
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NxStage Medical jumps on Baxter’s exit from the home hemodialysis market
Share prices for NxStage Medical (NSDQ:NXTM) jumped this week after Baxter (NYSE:BAX) CEO Joe Almeida said the company is pulling the plug on its Vivia home hemodialysis device. Almeida, speaking at...
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Study: Insurance restrictions on lumbar fusions push procedure volumes down
An insurance policy limit on lumbar fusion procedures helped slash costs and medically unnecessary surgeries in North Carolina, and the approach could work nationally, according to new research...
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Set your watches: Expected timing of European medical device regulations
By Ronald Boumans, Emergo Group Emergo has received questions about precise timelines regarding the introduction of new European Medical Device Regulations. This indicates there is a strong need within...
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House bill would force docs to report medical device problems to FDA
A bill expected to be introduced today in the U.S. House of Representatives would require doctors to tell the FDA about problems they encounter with medical devices. The “Medical Device Guardian’s...
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Tactile Systems sets terms for $60m IPO
Leg compression device developer Tactile Systems Technology set the terms for its initial public offering today, saying it plans to float 4 million shares at $14 to $16 apiece. At the midpoint, that...
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