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Study explores high-risk therapeutic devices approved through FDA's PMA pathway

Of high-risk therapeutic devices approved via the Food and Drug Administration Premarket Approval (PMA) pathway between 2010 and 2011, there has been wide variation in both the number and quality of premarket and postmarket studies, with approximately 13 percent of initiated postmarket studies completed between 3 and 5 years after FDA approval, according to a study in the August 11 issue of JAMA.

12 Aug 2015

Researchers describe new Lab-on-a-Disc device for fast and reliable diagnostics of urinary tract infections

Urinary tract infections can quickly move from being a merely miserable experience to a life-threatening condition. Untreated cases may trigger sepsis, which occurs when the immune system, in an attempt to fight off the infection, inadvertently activates body-wide inflammation that can cause blood clots and leaky blood vessels.

12 Aug 2015

St. Luke’s neurosurgeon partners with Medtronic to perform first live feed neurosurgery

St. Luke’s University Health Network’s functional neurosurgeon Steven Falowski, MD, has partnered with Medtronic medical device company to promote faster and better product development within the field of neuromodulation for patients with pain and disability related to nerve disorders.

7 Aug 2015

Health Canada approves Sorin’s Perceval sutureless aortic valve

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, today announced the Canadian approval of its Perceval sutureless aortic valve.

7 Aug 2015

Lightpoint Medical receives R01 grant from US National Cancer Institute

Lightpoint Medical, an innovative medical device company specializing in imaging technologies announced today that it has received an R01 grant of $2.6M million from the US National Cancer Institute. The funding will support clinical trials of Lightpoint's EnLight™ molecular imaging technology in lymph node cancer and a range of gynecologic cancers at Memorial Sloan Kettering Cancer Center.

6 Aug 2015

Lucideon and ReBioStent project partners to host Bioresorbable Materials for Medical Applications session at ESB 2015

Lucideon, the international materials technology company, along with its partners on the ReBioStent project, will be hosting a satellite session, “Bioresorbable Materials for Medical Applications”, at the European Society of Biomaterials (ESB) conference 2015 in Krakow, Poland on the 2nd of September.

From Lucideon 5 Aug 2015

Delcath Systems achieves record quarterly product revenue in Q2 2015

Delcath Systems, Inc., a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces financial results for the three and six months ended June 30, 2015.

5 Aug 2015

LifeBond announces closure of $27M Series D preferred equity investment

LifeBond, a leader in the development of bio-surgical medical devices for tissue repair, announced today it has closed a $27M Series D preferred equity investment. Participants in the round include Pitango Venture Capital, Adams Street Partners, Sino Biopharmaceutical Ltd., and all existing investors.

5 Aug 2015

Halyard Health’s net sales decrease $389 million to 6% in second quarter 2015

Halyard Health, Inc. today reported second quarter 2015 results and updated its net sales and adjusted diluted earnings per share outlook for full-year 2015.

4 Aug 2015

Cipher receives Acceptance Review Notification from FDA for 510(k) submission for Dermadexin

Cipher Pharmaceuticals Inc. today announced that it has received an Acceptance Review Notification for its 510(k) submission for Dermadexin to the U.S. Food & Drug Administration.

4 Aug 2015

Biosensors’ Q1 FY16 revenue reduces US$67.0M compared to US$80.2M in Q1 FY15

Biosensors International Group, Ltd., a developer, manufacturer and marketer of innovative medical devices, today announced financial results for its first fiscal quarter ended 30 June 2015 ("Q1 FY16").

3 Aug 2015

Exalenz Bioscience, Galectin Therapeutics to use BreathID test to assess GR-MD-O2 efficacy in NASH Cirrhosis patients

Exalenz Bioscience, a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced a collaboration with Galectin Therapeutics to use the BreathID test to monitor patients in a Phase II study evaluating GR-MD-02.

3 Aug 2015

Encision announces financial results for Q1 fiscal year 2016

Encision Inc., a medical device company owning patented surgical technology that prevents dangerous stray electrosurgical burns in minimally invasive surgery, today announced financial results for its fiscal 2016 first quarter that ended June 30, 2015.

3 Aug 2015

Takeda completes post-marketing commitment and data submission for pioglitazone containing medicines

Takeda Pharmaceutical Company Limited today announced the completion of the study to fulfill the post-marketing commitment and submissions of data to regulatory authorities from the Pan European Multi-Database Bladder Cancer Risk Characterization Study, a large (n= 112,674), multi-database retrospective matched cohort study, conducted in four European countries, for pioglitazone containing medicines, including ACTOS with up to 10 years of follow-up.

31 Jul 2015

Tissue Regenix strengthens position in post-acute wound care market with Medicare coverage for Dermapure

Tissue Regenix Group, the regenerative medical devices company, announces that it has further strengthened its position within the post-acute wound care market as Tissue Regenix Wound Care Inc. has received further approval for DermaPure under Medicare administrator, First Coast Service Options Inc. whose jurisdiction includes Florida, Puerto Rico and the US Virgin Islands.

30 Jul 2015

Novel 3D human skin tissue model could help detect presence of known skin sensitizers in medical device extracts

New research shows that exposing a 3D human skin tissue model to extracts of medical device materials can detect the presence of sensitizers known to cause an allergic response on contact in some individuals. Conventional skin sensitization testing of medical devices relies on animal testing, whereas human skin models could replace animal methods, according to an article in the new journal Applied In Vitro Toxicology, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers.

30 Jul 2015

New study reports creation of genetic porcine model of cancer

With many types of cancers, early detection offers the best hope for survival. However, research into new early-detection screenings, as well as possible interventional radiology and surgical treatments, has been hindered by the lack of a large animal model that would accurately reflect the types of cancers seen in human cells.

30 Jul 2015

RepliCel Life Sciences announces final design specifications for next-generation dermal injector

RepliCel Life Sciences Inc., a clinical stage regenerative medicine company, is pleased to announce that the final design specifications of its next-generation dermal injector (RCI-02) have been locked. Prototypes for industrial and regulatory testing will now be built to prepare for an application for CE mark clearance to market the injector in Europe in 2016.

29 Jul 2015

New polymer gel could help create swallowable devices for ultra-long drug delivery

Medical devices designed to reside in the stomach have a variety of applications, including prolonged drug delivery, electronic monitoring, and weight-loss intervention. However, these devices, often created with nondegradable elastic polymers, bear an inherent risk of intestinal obstruction as a result of accidental fracture or migration. As such, they are usually designed to remain in the stomach for a limited time.

29 Jul 2015

Sphere Medical publishes white paper discussing areas where Proxima mitigates sources of pre-analytical errors

Sphere Medical, innovator in critical care monitoring and diagnostics equipment, has published a white paper focusing on the mitigation of common pre-analytical errors associated with arterial blood gas analysis.

28 Jul 2015

Medical Devices News and Research

Study explores high-risk therapeutic devices approved through FDA's PMA pathway

Researchers describe new Lab-on-a-Disc device for fast and reliable diagnostics of urinary tract infections

St. Luke’s neurosurgeon partners with Medtronic to perform first live feed neurosurgery

Health Canada approves Sorin’s Perceval sutureless aortic valve

Lightpoint Medical receives R01 grant from US National Cancer Institute

Lucideon and ReBioStent project partners to host Bioresorbable Materials for Medical Applications session at ESB 2015

Delcath Systems achieves record quarterly product revenue in Q2 2015

LifeBond announces closure of $27M Series D preferred equity investment

Halyard Health’s net sales decrease $389 million to 6% in second quarter 2015

Cipher receives Acceptance Review Notification from FDA for 510(k) submission for Dermadexin

Biosensors’ Q1 FY16 revenue reduces US$67.0M compared to US$80.2M in Q1 FY15

Exalenz Bioscience, Galectin Therapeutics to use BreathID test to assess GR-MD-O2 efficacy in NASH Cirrhosis patients

Encision announces financial results for Q1 fiscal year 2016

Takeda completes post-marketing commitment and data submission for pioglitazone containing medicines

Tissue Regenix strengthens position in post-acute wound care market with Medicare coverage for Dermapure

Novel 3D human skin tissue model could help detect presence of known skin sensitizers in medical device extracts

New study reports creation of genetic porcine model of cancer

RepliCel Life Sciences announces final design specifications for next-generation dermal injector

New polymer gel could help create swallowable devices for ultra-long drug delivery

Sphere Medical publishes white paper discussing areas where Proxima mitigates sources of pre-analytical errors

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