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Medtronic wins 1st FDA nod for cement-augmented spine screws
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its CD Horizon fenestrated cement-augmented spinal pedicle screw set, designed to be used with Medtronic’s HV-R polymethylmethacrylate...
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FDA warns Oscor on process control records
The FDA last month warned contract manufacturer Oscor on its methods for documenting process controls for the catheters and neurostimulation leads it makes, after inspections in February and March...
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FDA readies panel on diabetes dosing label for Dexcom’s G5 CGM
The FDA yesterday released information on a panel its holding over Dexcom Inc.‘s (NSDQ:DXCM) G5 continuous glucose monitor, as the company seeks an expanded indication. The new indication would allow...
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Your inhaler’s watching you: drugmakers race for smart devices
(Reuters) – Makers of inhalers to treat asthma and chronic lung disease are racing to develop a new generation of smart devices with sensors to monitor if patients are using their puffers properly....
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MassDevice.com +5 | The top 5 medtech stories for July 20, 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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TE Connectivity gains on Q3 earnings beat
TE Connectivity (NYSE:TEL) shares are up today after the contract manufacturing giant beat expectations with its fiscal third-quarter earnings and said it would acquire German connector maker...
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Reflexion adds $6m to bring Series B to $52m
California-based medtech group RefleXion Medical said yesterday it extended its Series B round of financing, bringing in an extra $6 million to bring the total for the round up to $52 million....
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Philips acquires population health mgmt co. Wellcentive
Royal Philips (NYSE:PHG) said today it inked a deal to pick up population health management software dev Wellcentive for an undisclosed amount. Philips said the purchase would “compliment” its current...
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Ex-Acclarent CEO, sales VP escape felony charges, convicted on misdemeanors
UPDATED July 21, 2016, with verdict details, comment from defense lawyers. A federal jury today convicted 2 former Acclarent executives for the distribution of adulterated and misbranded medical...
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Xtant Medical ticks up on Q2 prelims
Xtant Medical saw shares tick up approximately 2% after releasing preliminary revenue figures for its 2nd quarter that saw and EBITDA up from its 1st quarter. The company said it expects to report...
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Bristol-Myers Squibb launches Orencia ClickJect drug-device combo for...
Bristol-Myers Squibb said today it launched the Orencia ClickJect autoinjector designed for the self-administration of Orencia to treat moderate to severe rheumatoid arthritis. The Orencia ClickJect is...
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Printing your skull: How 3D printing helps surgeons plan complex...
At five months’ gestation, Bentley Yoder was given little chance to live. A routine 20-week “gender reveal” ultrasound showed that a large portion of his brain was growing outside of his skull, a...
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FDA approves Vasorum’s Celt ACD vascular closure device
Vasorum said today that it won pre-market approval from the FDA for its Celt ACD vascular closure device. The Dublin-based company said the Celt ACD is designed to close punctures to the femoral artery...
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Medtronic recalls pacing leads on design standards snafu
Medtronic (NYSE:MDT) last month recalled 1 of its temporary pacing leads due to a design standards snafu. In a June 16 letter to customers who bought the leads, Fridley, Minn.-based Medtronic said its...
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Johnson & Johnson gets in on 3D printing with Materialise deal for titanium...
Johnson & Johnson (NYSE:JNJ) said this week that it inked a deal with 3D printing shop Materialise for titanium craniofacial implants customized to individual patients’ anatomies. Leuven,...
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Hologic inks marketing deal with Bovie Medical for J-Plasma surgical tool
Bovie Medical (NYSE:BVX) said today it inked a sales channel partnership deal with Hologic, (NSDQ:HOLX) adding Bovie’s J-Plasma product line to its portfolio. The deal, which goes into effect...
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FlexDex Surgical closes $5m Series B, preps launch of laparoscopic tools
FlexDex Surgical said today that it raised a $5 million Series B round it plans to use to advance the laparoscopic surgery tools it’s developing. Get the whole story at our sister site, Medical Design...
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LifeBond wins FDA IDE clearance for LifeSeal sealant kit
LifeBond said today it won an Investigational Device Exemption from the FDA to initiate a clinical study of its LifeSeal surgical sealant kit. The company’s LifeSeal kit includes a specific...
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InfoBionics, BioTelemetry each claim win in patent spat
Both BioTelemetry (NSDQ:BEAT) and digital health startup InfoBionic celebrated victory in their patent fight with each other over wireless cardiac monitoring technology. But the battle is far from...
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Tandem Diabetes to integrate TypeZero’s artificial pancreas tech
Tandem Diabetes Care (NSDQ:TNDM) said today it inked a license agreement with TypeZero Technologies to integrate TypeZero’s artificial pancreas into Tandem’s next-gen t:slim insulin pump. TypeZero’s...
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