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- Feed Preview FDA Device Approvals Coverage - MedCity News
FDA finalizes new breakthrough device designation rule
The larger regulatory modernization efforts, which include updates to the 510(k) regulatory approval pathway and the DeNovo Clearance review process are part of the FDA’s Medical Device Saf...
https://medcitynews.com/2019/01/fda-finalizes-new-breakthrough-device-designation-rule/
FDA considering imposing 10-year limit when manufacturers choose older predicates
FDA is modernizing its 510(k) program and one change it is mulling is placing a limit on how old a predicate device is when manufacturers develop a new product showing substantial equivalence...
An alarming device trend: Why getting 510(k) clearance alone is not enough
Don’t be like Acme Medical Device Company. The post An alarming device trend: Why getting 510(k) clearance alone is not enough appeared first on MedCity News .
https://medcitynews.com/2015/12/why-getting-510k-clearance-not-enough/
‘Parallel review’ pilot by FDA, CMS will speed up Medicare coverage for new cancer test
Medicare beneficiaries may get speedier coverage for a newly approved screening test for colorectal cancer under a pilot project in which two federal agencies reviewed the product at the same ti...
FDA clearance for augmented reality device lets surgeons see each critical step before they make it
Medical device startup, Surgical Theater, was inspired by flight simulators for its augmented reality imaging devices to help physicians prep for surgery. Its Surgical Navigation Advanced Platfor...
Robotics milestone: FDA clears motorized exoskeleton to help paralyzed patients walk
A motorized exoskeleton designed to help some of the 200,000 people in the U.S. with lower body paralysis has won clearance from the FDA to market the device in the U.S., according to a company a...
FDA approves Gauss Surgical’s app that turns iPads into real-time surgical blood loss monitors
A system that uses an iPad camera and cloud analytics to help anesthesiologists monitor how much blood a patient is losing during surgery has gotten the FDA’s OK for use in the operating room. ...
https://medcitynews.com/2014/05/gauss-surgicals-app-turns-ipad-real-time-blood-loss-monitor/
FDA clears obstructive sleep apnea implant to overcome adherence issues
Sleep is like sex. Everybody wants it and nobody is getting enough. That’s what Lars Knutsen of Requis Pharmaceuticals said the other day as part of a presentation for a snoring and sleeplessne...
FDA medical device proposal would develop faster path to market for breakthrough tech
Washington routinely comes in for criticism that it doesn’t do enough to support the U.S. medical device industry. But a new FDA proposal would establish for medical devices the equivalent of i...
Verizon gets FDA clearance to expand remote monitoring platform to iOS users
Verizon has received FDA clearance that will expand a physician-facing patient engagement tool to capture patient data between office visits to the iOS network, according to a company statement. ...
EarlySense gets FDA device approval for patient monitor update with benchmarking tool
Medical device maker EarlySense has received a green light for an updated version of its FDA-approved patient monitoring device. The tool uses a pad-sized sensor that fits under the mattress to t...
Texas medical device company scores FDA nod for hammertoe fixation system
San Antonio, Texas-based BioMedical Enterprises received FDA clearance for its HammerLock Nitinol Intramedullary Fixation System upgrade. The system’s original innovation? No wires. The upgra...
https://medcitynews.com/2013/11/texas-medical-fda-device-approval-hammertoe-fixation/
FDA to 23andMe: Stop selling spit kits
Star startup 23andMe got slammed with an FDA warning letter Nov. 22. The letter says the healthcare startup’s genetic testing spit kits are being marketed without clearance or approval. It goes...
https://medcitynews.com/2013/11/23andme-receives-fda-warning-letter-spit-kits-violation/
BSX scores FDA device approval for drug-eluting stent for coronary artery disease patients
Boston Scientific (BSX) received FDA device approval for its Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, a next-gen polymer drug-eluting stent. The product launche...
Illumina gets FDA greenlight for first set of next generation sequencing devices
Illumina (NASDAQ: ILMN) got marketing authorization from the U.S. Food and Drug Administration for its diagnostic devices for next generation gene sequencing or NGS. Two of the devices focus on...
Boston Scientific gets FDA clearance and CE Mark for embolization catheter
Boston Scientific (BSX) received FDA clearance and the CE Mark for its Direxion Torqueable Microcatheter. The catheter is the company’s newest addition to its peripheral embolization medical d...
https://medcitynews.com/2013/11/boston-scientific-gets-fda-clearance-ce-mark-embolization-catheter/
Wow of the week: The mermaid treatment? Fish skin as chronic wound healing tech for diabetics
Could the answer for diabetic ulcers and other chronic wounds be found under the sea? A new wound healing treatment is one part tissue regeneration technology and one part Little Mermaid. It isn...
5 Ways mobile Is revolutionizing medical device sales
Mobile technology has dramatically changed how many people and industries do work, and it is revolutionizing medical device sales — or it at least has the potential to. Properly implemented, an...
https://medcitynews.com/2013/11/5-ways-mobile-revolutionizing-medical-device-sales/
Deaths, problems with robotic surgical systems not being reported to FDA
The use of robotic surgical systems is expanding rapidly, but hospitals, patients and regulators may not be getting enough information to determine whether the high tech approach is worth its cos...
https://medcitynews.com/2013/11/deaths-problems-robotic-surgical-systems-reported-fda/
EndoChoice wins FDA 510(k) clearance for gastroscope with wider field of view
EndoChoice, an Atlanta, Ga.-based healthcare startup, announced it’s received 510(k) clearance for its Fuse Gastroscope. It’s not the first positive FDA device approvals news the company has ...
https://medcitynews.com/2013/10/endochoice-wins-fda-510k-clearance-gastroscope-wider-field-view/
FDA device approval imminent? Impressive CoreValve data allows Medtronic to skip advisory panel
Medtronic (MDT) presented such good results from its pivotal trial on the CoreValve at the Transcatheter Cardiovascular Therapy conference, the company announced the FDA will consider device appr...
FDA clears Glooko’s mobile diabetes management system for Android
Glooko, Inc. received an FDA nod for its Android compatible version of its next-generation diabetes management system. According to a company statement, this system is now “the only FDA-cleared...
FDA grants Neuros Medical IDE approval to conduct clinical trial for pain management technology for amputees
Neuros Medical, a Cleveland-based medical device company, received an FDA investigational device exemption approval to begin a clinical study on its technology for intractable limb pain managemen...
FDA advisory panel gives mixed message to STJ fave CardioMEMS on CHAMPION implantable device
After a difficult premarket approval process and tenuous relationship with the FDA, Atlanta’s CardioMEMS received a mixed message from an FDA advisory panel on its CHAMPION HF Pressure Measur...
Tennessee medical device company gets FDA nod for Occlusion Perfusion Catheter
Chattanooga, Tenn.-based Advanced Catheter Therapies received FDA 510(k) clearance for its Occlusion Perfusion Catheter, a multi-lumen balloon catheter on Tuesday. The medical device technology c...
Biotronik receives FDA device approval for ‘smaller, thinner’ one-lead implantable cardiac defibrillator
Biotronik, an Oregon-based cardiovascular medical device company, announced it received final FDA device approval for its Ilesto DX, an implantable cardiac defibrillator. Earlier this year, it r...
Cigna chief medical officer says ‘gap of hopefulness’ separates FDA approval & reimbursement
Cost effectiveness and outcomes drive value for payers, Cigna‘s Chief Medical Officer Alan Muney said. While some medical device companies assume an FDA approval will mean a definite reimbursem...
Exclusive training will teach the FDA approval process for cardiovascular clinical trials
IMARC and CardioMed have partnered to offer an exclusive training specifically geared to explain the FDA approval process for cardiovascular clinical trials. Drawing on expert speakers from the c...
GI gets FDA nod for PillCam SB, plans for big Q4
The third generation of Given Imaging‘s PillCam SB got FDA approval today, and President and CEO Homi Shamir said the product should launch in October of this year. The device, a capsule with a...
https://medcitynews.com/2013/08/gi-gets-fda-nod-for-pillcam-sb-plans-for-big-q4/
FDA approves Medtronic’s neurostimulation implant that can withstand full-body MRI
Medtronic makes history in neurostimulation devices today, receiving FDA-approval for the first implantable spinal cord stimulation systems for use in the treatment of back pain for conditiona...