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Cohera Medical Inc.

FDA awards priority review status to Cohera Medical’s surgical sealant Sylys | Regulatory news for the week of December 22, 2014

December 23, 2014 By MassDevice Leave a Comment

Cohera's Sylys sealant wins quick review at FDA

December 18, 2014 by Val Kennedy

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Bio2 Technologies, Cerus Corp., Cohera Medical Inc., CVRx Inc., Sorin Group

Cohera’s Sylys sealant wins quick review at FDA

December 19, 2014 By Val Kennedy Leave a Comment

Cohera's Sylys sealant wins quick review at FDA

The FDA awarded priority review status to Cohera Medical‘s surgical sealant Sylys because the product addresses a significant unmet medical need.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Surgical Tagged With: Cohera Medical Inc.

Medical device makers find new layer of regulation before earning CE Mark approval | Regulatory news for the week of August 4, 2014

August 5, 2014 By MassDevice Leave a Comment

Medical device makers face new obstacles to European approval

July 30, 2014 by Arezu Sarvestani

Medical device makers face new obstacles to CE Mark

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Cohera Medical Inc., EDAP TMS SA, European Commission

FDA panel narrowly OKs Cohera Medical’s TissuGlu

August 1, 2014 By Ingrid Mezo Leave a Comment

Updated August 4, 2014 at 11:30 a.m. with comments from panel members.

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The FDA’s General & Plastic Surgery Devices Advisory Panel today narrowly recommended approval for Cohera Medical‘s polyurethane-based TissuGlu adhesive for the approximation of tissue layers to bind subcutaneous dead space between the tissue planes in large flap surgical procedures, including abdominoplasty.

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Surgical Tagged With: Cohera Medical Inc., Tissue sealer

FDA opens up about chat with Apple on company’s healthcare prospects | Regulatory news for the week of June 16, 2014

June 17, 2014 By MassDevice Leave a Comment

Digital health: Inside Apple’s meeting with the FDA

June 10, 2014 by Arezu Sarvestani

Digital health: Inside Apple's meeting with the FDA

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Apple, Booz Allen Hamilton, C.R. Bard, Cohera Medical Inc.

Cohera Medical wins FDA panel date for TissuGlu surgical adhesive

June 10, 2014 By Brad Perriello Leave a Comment

Cohera Medical wins FDA panel date for TissuGlu surgical adhesive

Cohera Medical said it’s won a date with an FDA advisory panel in August for its TissuGlu surgical adhesive.

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Surgical Tagged With: Cohera Medical Inc., Tissue sealer

Echo Therapeutics in midst of a proxy battle with Platinum Management | Medtech personnel moves for the week of Apr. 28, 2014

April 30, 2014 By MassDevice Leave a Comment

Echo Therapeutics in proxy battle with largest shareholder

April 25, 2014 by Brian Johnson

Echo Therapeutics releases CE Mark regulatory trial results for Symphony CGM system

Filed Under: News Well Tagged With: AdvaMed, Cohera Medical Inc., Echo Therapeutics Inc., Fujifilm, Mercator MedSystems, OrbusNeich, Orthofix, Personnel Moves, Sanovas, SANUWAVE Health Inc., T2 Biosystems Inc., Uroplasty Inc., Vascular Pathways Inc.

Orthofix names interim CFO, taps CareFusion CFO for board | Personnel Moves

April 28, 2014 By Brad Perriello

Orthofix names interim CFO, taps CareFusion CFO for board | Personnel Moves

Filed Under: News Well, Wound Care Tagged With: AdvaMed, Cohera Medical Inc., Fujifilm, Mercator MedSystems, OrbusNeich, Orthofix, Personnel Moves, Sanovas, SANUWAVE Health Inc., T2 Biosystems Inc., Uroplasty Inc., Vascular Pathways Inc.

Cohera Medical touts $26M Series D funding

January 23, 2014 By Chris Walker Leave a Comment

Cohera Medical closes $26M Series D round

Cohera Medical closed its Series D financing round, bringing in $26.3 million which will be dedicated to securing FDA clearance for its TissuGlu surgical adhesive and CE Mark approval for the Sylys surgical sealant.

Filed Under: Funding Roundup, News Well, Surgical Tagged With: CE Mark, Cohera Medical Inc.

Cohera completes clinical trial for surgical sealant

December 18, 2013 By Chris Walker Leave a Comment

Cohera completes clinical trial for surgical sealant

Cohera Medical put a bow on the clinical trial for its Sylys surgical sealant, saying that it confirmed the safety of the leakage-preventing product.

Sylys is a synthetic sealant "specifically designed to significantly reduce anastomotic leakage in intestinal anastomosis procedures," used in conjunction with standard anastomotic closure techniques. Sylys supports anastomosis during the 1st few days of healing, when leaks are most likely to occur.

Filed Under: News Well, Surgical Tagged With: Clinical Trials, Cohera Medical Inc.

Cohera completes PMA application for surgical adhesive

November 21, 2013 By Chris Walker Leave a Comment

Cohera completes PMA application for surgical adhesive

Cohera Medical announced that it submitted the 4th and final module of its FDA pre-market approval application for its TissuGlu surgical adhesive.

The 4th module is comprised of data from the Pittsburgh based-company’s ‘No Drain’ study, in which the adhesive was proven to be a “clinically superior alternative to closed-suction drains for fluid management in large flap procedures,” according to the press release.

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Cohera Medical Inc.

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