Topic: FDA device approvals

Learn about the latest FDA device approvals and related trends in the medical device industry. Read about which companies have received FDA device approvals, which were rejected by the U.S. Food and Drug Administration, and about FDA policy changes that will impact medical device companies and other life science current events.
FDA to 23andMe: Stop selling spit kits

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FDA to 23andMe: Stop selling spit kits

November 25, 2013 12:11 pm by | 2 Comments

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…


Verizon gets FDA clearance to expand remote monitoring platform to iOS users

Verizon gets FDA clearance to expand remote monitoring platform to iOS users

February 25, 2014 2:39 pm by | 1 Comments

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. The…


Medtronic’s new heart valve replacement system gets FDA approval

Medtronic’s new heart valve replacement system gets FDA approval

January 17, 2014 11:04 am by | 1 Comments

(Reuters) – Medtronic Inc’s non-invasive systems for replacing diseased heart valves won U.S. approval for use in patients deemed too frail to endure traditional open heart surgery, the U.S. medical…



EarlySense gets FDA device approval for patient monitor update with benchmarking tool

EarlySense gets FDA device approval for patient monitor update with benchmarking tool

January 8, 2014 2:38 pm by | 1 Comments

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…


Magnetic medical device helps acid-reflux disease sufferers

Magnetic medical device helps acid-reflux disease sufferers

December 7, 2013 2:14 am by | 1 Comments

Acid reflux disease was making Jeff Pugh’s life miserable. Like millions of Americans, he took medications to suppress and counteract the digestive juices that backed up from his stomach into…


Texas medical device company scores FDA nod for hammertoe fixation system

Texas medical device company scores FDA nod for hammertoe fixation system

November 27, 2013 9:47 am by | 1 Comments

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 upgrade has a linear body that allows more bone…


BSX scores FDA device approval for drug-eluting stent for coronary artery disease patients

BSX scores FDA device approval for drug-eluting stent for coronary artery disease patients

November 25, 2013 9:55 am by | 0 Comments

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 launches immediately in the U.S. It will…


Illumina gets FDA greenlight for first set of next generation sequencing devices

Illumina gets FDA greenlight for first set of next generation sequencing devices

November 20, 2013 3:52 pm by | 0 Comments

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 gets FDA clearance and CE Mark for embolization catheter

November 20, 2013 10:52 am by | 0 Comments

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 device technology portfolio. Radiologists…


Wow of the week: The mermaid treatment? Fish skin as chronic wound healing tech for diabetics

Wow of the week: The mermaid treatment? Fish skin as chronic wound healing tech for diabetics

November 9, 2013 9:19 am by | 2 Comments

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…


5 Ways mobile Is revolutionizing medical device sales

5 Ways mobile Is revolutionizing medical device sales

November 5, 2013 8:00 am by | 2 Comments

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,…


Deaths, problems with robotic surgical systems not being reported to FDA

Deaths, problems with robotic surgical systems not being reported to FDA

November 1, 2013 5:41 am by | 0 Comments

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…


EndoChoice wins FDA 510(k) clearance for gastroscope with wider field of view

EndoChoice wins FDA 510(k) clearance for gastroscope with wider field of view

October 31, 2013 3:52 pm by | 0 Comments

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 gotten this year…


FDA device approval imminent? Impressive CoreValve data allows Medtronic to skip advisory panel

FDA device approval imminent? Impressive CoreValve data allows Medtronic to skip advisory panel

October 30, 2013 3:50 pm by | 0 Comments

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 approval without the…


FDA clears Glooko’s mobile diabetes management system for Android

FDA clears Glooko’s mobile diabetes management system for Android

October 29, 2013 6:30 am by | 4 Comments

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 mobile…


FDA panel concludes benefits of CarioMEMS’ remote monitoring device outweigh risks

FDA panel concludes benefits of CarioMEMS’ remote monitoring device outweigh risks

October 12, 2013 9:55 am by | 0 Comments

Atlanta-based CardioMEMS Inc., developer of an implantable wireless device that helps physicians monitor blood pressure in heart patients, may be breathing a little easier following a federal panel’s finding that…