ANNOUNCEMENT

These 11 companies will be featured in the MedCity ENGAGE Innovation Showcase June 5-6 in Washington, D.C.

Topic: FDA Approval

FDA approves Bayer drug for rare gastrointestinal tract cancer

FDA approves Bayer drug for rare gastrointestinal tract cancer

February 25, 2013 2:08 pm by | 0 Comments

WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Monday it has approved Bayer AG's drug Stivarga for the treatment of a rare type of gastrointestinal tract cancer.Stivarga ... Read more
Beyond the hype of the FDA’s approval of the first bionic eye

Beyond the hype of the FDA’s approval of the first bionic eye

February 14, 2013 6:01 pm by | 0 Comments

It’s easy to get excited when really intriguing and previously unthinkable technology reaches the marketplace.For example, there’s been a lot of hype in the news leading up to the U.S. ... Read more
FDA clears Conventus Orthopaedics’ less invasive treatment to repair wrist fractures

FDA clears Conventus Orthopaedics’ less invasive treatment to repair wrist fractures

January 28, 2013 11:55 am by | 0 Comments

Minnesota orthopaedics device startup Conventus Orthopaedics announced Monday that the U.S. Food and Drug Administration has approved its minimally invasive treatment for repairing wrist fractures.The Conventus Distal Radius Surgical System ... Read more
FDA OKs over-the-counter version of Merck overactive bladder drug

FDA OKs over-the-counter version of Merck overactive bladder drug

January 25, 2013 11:36 am by | 0 Comments

(Reuters) - U.S. health regulators approved a nonprescription version of Merck & Co Inc's Oxytrol to treat overactive bladder in women ages 18 and older, the agency said on Friday.The ... Read more
Breast cancer detection device for the OR inches closer to pre-market approval

Breast cancer detection device for the OR inches closer to pre-market approval

November 19, 2012 11:53 am by | 0 Comments

Dune Medical Devices announced Monday that the company has received a letter from the Food and Drug Administration indicating that it is close to receiving a pre-market approval from the ... Read more
Norwegian maker of ultrasound bladder scanners wins FDA nod, launches product

Norwegian maker of ultrasound bladder scanners wins FDA nod, launches product

November 16, 2012 11:27 am by | 0 Comments

The Food and Drug Administration has cleared an ultrasound bladder scanner made by Norwegian firm Vitacon AS to diagnose bladder dysfunction and the firm has signed a marketing agreement that ... Read more
FDA clears ablation treatment that gynecologists can use to treat uterine fibroids in women

FDA clears ablation treatment that gynecologists can use to treat uterine fibroids in women

November 6, 2012 12:11 pm by | 0 Comments

Halt Medical, a medical device company based in Brentwood, California, announced Tuesday that the Food and Drug Administration has cleared its Acessa device that gynecologists can use to treat female ... Read more
Utah startup Amedica gets FDA clearance for interbody spinal fusion device system

Utah startup Amedica gets FDA clearance for interbody spinal fusion device system

September 27, 2012 10:53 am by | 0 Comments

Salt Lake City, Utah-based Amedica announced Thursday that it has received regulatory clearance for the second generation of an interbody fusion device system.The U.S. Food and Drug Administration has cleared ... Read more
FDA clears Roche Diagnostics’ tests to diagnose herpes viruses

FDA clears Roche Diagnostics’ tests to diagnose herpes viruses

September 4, 2012 12:32 pm by | 0 Comments

Roche Diagnostics Corp. announced Tuesday that the company has received clearance from the Food and Drug Administration to market two automated tests for herpes simplex virus 1 and 2.The tests ... Read more
Roche receives FDA ok for herpes tests for HSV-1, HSV-2 infections

Roche receives FDA ok for herpes tests for HSV-1, HSV-2 infections

September 4, 2012 11:01 am by | 0 Comments

Roche (OTC: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IgG Antibody to herpes simplex virus (HSV) types 1 and ... Read more
Lilly gets FDA approval for prescribing Tradjenta tablets

Lilly gets FDA approval for prescribing Tradjenta tablets

August 17, 2012 2:58 pm by | 0 Comments

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Tradjenta ... Read more
Subsidiary of Depuy Synthes receives FDA approval for implantable device that treats spasticity

Subsidiary of Depuy Synthes receives FDA approval for implantable device that treats spasticity

August 7, 2012 2:42 pm by | 0 Comments

Codman & Shurtleff Inc., part of the Depuy Synthes companies, announced Tuesday that it has received a premarket approval from the U.S. Food and Drug Administration to market a neuromodulation ... Read more
Fecal incontinence test technology licensed from Mayo wins FDA approval

Fecal incontinence test technology licensed from Mayo wins FDA approval

May 21, 2012 2:25 pm by | 0 Comments

A fecal incontinence test has won regulatory approval, announced the company that originally licensed the technology from the Mayo Clinic in 2009.Medspira, based in Minneapolis, said the U.S. Food and ... Read more
CE mark or FDA approval? Medical device professionals weigh in

CE mark or FDA approval? Medical device professionals weigh in

February 27, 2012 12:15 pm by | 1 Comments

With the ever-increasing stringency, time, and expense associated with FDA approval for medical devices, debate is sharpening in the medical devices industry over whether it is actually better business strategy ... Read more