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J&J’s Ethicon touts Evarrest in study of aortic repair
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon is touting a Phase III clinical study of its Evarrest fibrin sealant patch in surgeries to repair the aorta, saying the patch handily beat Baxter‘s...
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FDA approves trial for Inari Medical’s clot-busting FlowTriever
Inari Medical said today that it won an investigational device exemption from the FDA for a clinical trial of its FlowTriever device, which is designed to retrieve pulmonary embolisms. Irvine,...
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OrthoSensor inks collaborative dev deal with IM-Tech
OrthoSensor said today it inked a strategic partnership agreement with electronic component maker IM-Tech that includes development collaboration, manufacturing and capital investment. The companies...
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Becton Dickinson deals controlling half of respiratory business to Apax Partners
Becton Dickinson & Co. (NYSE:BDX) said today that it inked a deal to sell a 50.1% stake in its respiratory business to private equity giant Apax Partners for an undisclosed amount, forming a joint...
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Changes to the FDA routine inspection plan: Will this help the FDA?
In the clinical research industry, approvals for investigational products are not granted- they are earned. Increasing numbers of FDA early-intervention and routine inspections can increase the stress...
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BioStable Science & Engineering wins CE Mark for annuloplasty device
Cardiovascular device company BioStable Science & Engineering said today it won CE Mark approval in the European Union for its HAART 300 aortic annuloplasty device designed for aortic valve repair....
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InVivo continues Inspire study expansion, adds Thomas Jefferson Univ. Hospital
InVivo Therapeutics (NSDQ:NVIV) shows no signs of stopping the momentum in its Inspire trial, announcing today that it added Philadelphia’s Thomas Jefferson University Hospital as a clinical site for...
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Bill Hawkins on his time at Medtronic, Immucor and 25 years in the hot seat |...
For nearly a quarter of a century, William “Bill” Hawkins sat in the corner office of medtech companies of all sizes, before stepping down from Immucor last year to become the Atlanta-based company’s...
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FDA warns on mag interference between breast expanders, ICD/pacers
The FDA today released a letter warning on magnetic interference issues between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators or pacemakers. The federal...
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MassDevice.com +3 | The top 3 medtech stories for March 8, 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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LivaNova touts 1st U.S. implants of Perceval sutureless valve
LivaNova (NSDQ:LIVN) today announced the 1st U.S. implantation of its Perceval sutureless aortic valve replacement. The implantation, which took place last week, was headed by Dr. Douglas Johnson and...
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Toyota developing wearable navigation device for the blind
Toyota (NSDQ:ADR) said today it is developing a wearable device, under the name project Blaid, for the blind and visually impaired to aid in indoor navigation and mobility. The device, which Toyota...
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Nanovis wins NIH grant for FortiCore
Regenerative life sciences company Nanovis said today it won a grant from the National Institute of Health’s National Institute on Aging to fund pre-clinical studies of its FortiCore interbody fusion...
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US FDA plans up-classification of blood lancets
By Stewart Eisenhart, Emergo Group US regulators have proposed reclassifying three major types of medical devices used to obtain blood samples for diagnostic purposes from Class I to Class II or III....
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Canon wins exclusive negotiating rights for Toshiba Medical
Canon (NYSE:CAJ) beat out Fujifilm Holdings (TSE:4901) for the exclusive right to negotiate with Toshiba (TYO:6502) for its medical device business, the embattled Japanese conglomerate said today....
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UL provides medical device manufacturers alternative to traditional CFDA testing
UL, a global safety science organization, announced the launch of its new China Food and Drug Administration (CFDA) testing program for medical device manufacturers. This program allows medical device...
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Report: Medtronic scales back at former Covidien HQ in Mass.
Medtronic (NYSE:MDT) is scaling back in Mansfield, Mass., as it looks to cut costs at the former headquarters of its Covidien subsidiary.* Medtronic spokesman Fernando Vivanco told MassDevice.com...
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PMT Corp. must pay $1m to end EEOC case
PMT Corp. must pony up nearly $1.1 million to settle a lawsuit brought by the U.S. Equal Employment Opportunity Commission alleging that the medical device maker refused to hire women and people over...
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Japan OKs NuVasive’s Reline spine fixation system
NuVasive Inc. (NSDQ:NUVA) said today that it’s planning a launch later this year for its Reline posterior fixation system in Japan, after winning Shonin approval there. The approval is the final hurdle...
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UPDATE: FDA warns Repro-Med on Freedom Infusion set issues
Updated with comment from Repro-Med Systems The FDA today released a warning letter it sent to Repro-Med Systems over issues it found with the company’s Freedom 60 syringe infusion pump and Freedom...
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