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Monitoring Concussions from the Sidelines with a Mobile App

February 18, 2013 7:29 am | by Mass Device | News | Comments

Massachusetts researchers developed a smartphone app that doctors may be able to use to monitor neurological activity on the go. The app may make a big splash among sports doctors who need to keep an eye on the health of athletes at risk of traumatic brain injury.


Study of Infants in Neonatal ICU Shows Low BPA Exposures Are Well Within Safe Limits

February 17, 2013 12:27 pm | by Bio-Medicine.Org | News | Comments

WASHINGTON , Feb. 18, 2013 /PRNewswire-USNewswire/ -- A study published today in Pediatrics attempted to determine whether feeding sources (breast milk or formula) or needed medical devices were the sources of BPA exposure among premature infants under medical care in a hospital intensive care unit. 

Columbia Asia Referral Hospital, Yeshwanthpur, Successfully Conducts HOLEP to Treat a 72-Year-old With Urology Disorder

February 17, 2013 12:27 pm | by Bio-Medicine.Org | News | Comments

BANGALORE , February 18, 2013 /- Columbia Asia Referral Hospital, Yeshwanthpur (CARHY) successfully conducted a Urology surgery through an advanced laser technology - HOLEP. The team of doctors led by  Dr Manohar,  Consultant Urologist at CARHY removed a large prostate gland weighing 350 gms, hitherto unheard of in medical history. "HOLEP by 100 Watt Hol...


Abbott's MitraClip Gets a Date with the FDA

February 15, 2013 2:28 pm | by Mass Device | News | Comments

The FDA's Circulatory System Devices Panel will review data and make recommendations on Abbott's MitraClip aortic valve repair system. Abbott (NYSE:ABT) landed an FDA panel date to review its MitraClip aortic valve repair system, according to an FDA notice.


Stryker to Present at Investor Conferences

February 15, 2013 1:48 pm | by The Associated Press | News | Comments

Kalamazoo, Michigan - February 15, 2013 - Stryker Corporation (NYSE:SYK) announced today that it will participate in the following investor conferences: February 25, 2013 - 10:20 a.m. Eastern Time Citi 2013 Global Healthcare Conference New York, New York March 5, 2013 - 10:40 a.m. Eastern Time...


Heraeus Expands Its Venus White Line of Whitening Maintenance and Oral Care Products

February 15, 2013 1:48 pm | by Bio-Medicine.Org | News | Comments

SOUTH BEND, Ind. , Feb. 15, 2013 /- Heraeus Kulzer, LLC, the worldwide leader in dental esthetics, announced today that it has expanded the scope of its Venus White line to include four new oral care and whitening products that will become part of the Venus Whitening and Oral Care family of products.


FDA Approvies Lombard Med. Tech.'s Aorfix Stent Graft for Treating Highest Neck Angulation

February 15, 2013 1:24 pm | by Mass Device | News | Comments

British medical device maker Lombard Medical Technologies won premarket approval from the FDA to market its Aorfix flexible stent graft in the U.S. The FDA win gives Lombard permission to market the Aorfix device in treatment of challenging neck angulations from the range of 0 to 90 degrees.


Hypertension: ReCor Launches Post-Market Study of Next-Gen Paradise System

February 15, 2013 12:26 pm | by Mass Device | News | Comments

California medical device startup ReCor Medical launched a post-market study of its next-generation Paradise renal denervation system in treatment of patients with resistant high blood pressure. The 50-patient study has already enrolled patients at a participating facility in the Netherlands with the Paradise device.


St. Jude Looks Beyond Blood Pressure for Benefits of Renal Denervation

February 15, 2013 12:06 pm | by Mass Device | News | Comments

St. Jude Medical is aiming to take its renal denervation therapy a step further, looking for signs that the minimally invasive treatment improves health beyond lowering high blood pressure in patients with uncontrolled hypertension. The company's new Enlightnment trial is looking for long-term effects of renal denervation therapy...


St. Jude Medical Initiates Landmark Study of Renal Denervation for Reduction of Heart Attack, Stroke and Death

February 15, 2013 8:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--Feb 15, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced plans for a new landmark study that will evaluate whether renal denervation and medication can provide health benefits to patients beyond lowering high blood...


Patient Safety Advocates Declare War on Preventable Deaths

February 15, 2013 7:29 am | by Mass Device | News | Comments

Patient monitoring devices maker Masimo this week touted the "great success" of its 1st Patient Safety, Science & Technology Summit, touting a groundswell of support from hospitals and medical technology companies. Masimo updated its progress toward its stated goal of eliminating preventable deaths by 2020, illustrating the problem with a couple of grim examples.

BAROnova@ Secures $27.3M Investment To Fund Clinical Trial For Weight-loss Device

February 15, 2013 6:02 am | by The Associated Press | News | Comments

BAROnova, Inc., announced today the closing of its Series C financing of $27.3 million, led by investments from Sante Ventures and Boston Scientific Corporation (NYSE:BSX), a leading innovator of medical devices and technologies.  Participants included Series B investors ONSET Ventures,...

Cohera Medical, Inc.@ Raises $17 Million in Series D Round

February 15, 2013 6:00 am | by The Associated Press | News | Comments

Cohera Medical, Inc.@, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has secured $17 million towards Series D financing through private investors. The milestone comes from raising an additional $7.3 million in the Company's latest offering, in addition to the $9.7 million raised in 2012.


BIOTRONIK Ilesto 7 ICD/CRT-D Series With ProMRI(R) Technology Gains CE Approval

February 15, 2013 4:00 am | by The Associated Press | News | Comments

BIOTRONIK, the leading manufacturer of cardiovascular medical technology that is celebrating its 50th anniversary in 2013, announced today that the Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series has received CE...


Draft Guidance for Industry and Food and Drug Administration Staff - Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act

February 15, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Section 302 of Title III of the Food and Drug Administration Amendments Act of 2007 (FDAAA), created Section 515A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e). Section 515A requires submitters to FDA of premarket approval..



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