News

Oncoscope closed on $890,737 of a $2 million round.  The company is developing a novel imaging technology for early cancer diagnosis.  www.oncoscope.com.

As a reference, WallSt 24/7 recently published this analysis of the US Implantable Device market. Read the full article here.  Ranked by numbers of procedures:

11. Implantable Cardioverter Defibrillators (ICDs) [133,262]

10. Artificial Hips [230,000]

 9. Heart Pacemakers [235,567]

 8. Breast Implants [366,000]

 7. Spine Screws, Rods, and Artificial Discs (Spinal-Fusion Hardware) [413.000]

 6. Intrauterine Devices (IUDs) [425,000]

 5. Metal Screws, Pins, Plates, and Rods (Traumatic Fracture Repair) [453,000]

 4. Artificial Knees [543,000]

 3. Coronary Stents [560,000]

 2. Ear Tubes (Tympanostomy Tubes) [715,000]

 1. Artificial Eye Lenses (Pseudophakos/Intraocular Lens) [2,582,000]
 

FDA is pushing into the mobile applicationse as it seeks comments on Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications. Also read the following recap from QMED. 

Morrisville based nContact, Inc. (nContact), the leading minimally invasive epicardial ablation device manufacturer, reports with interest an article published in the European Journal of Cardio-thoracic Surgery that demonstrates the importance of a comprehensive epicardial lesion pattern combined with diagnostics to confirm conduction block in radiofrequency ablation for the successful treatment of persistent and long standing persistent atrial fibrillation (AF). Read more here.

The company will annouce the big news today and begin to ramp up manufacturing and sales operations.  Read the News and Observer recap here.   

In case you missed these - FDA released two important guidances in June related to drug device combinations - an area of strength in NC.  Please take a look at Classification of Products as Drugs and Devices and Additional Product Classification Issues and Interpretation of the Term "Chemical Action" in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act. 

New technology, developed by Dr. Andrew Armstrong, a researcher at Duke Cancer Institute, and his team can improve the ability to view how cancer cells navigate the blood.  This could improve the accuracy of certain blood tests that detect cancer, as well as inform physicians on the effects of cancer treatments.  The study was published in the journal, Molecular Cancer Research.  For more information, click here.  

The Medical Device and Manufacturers Association (MDMA) is putting together a letter to congressional leaders to ask for the repeal of the medical device excise tax.  The letter will include the names of hundreds of device companies and venture capital investors that are working together to try to remove this tax.  If you would like to support this effort by being included on this letter, please e-mail your name, company affiliation, and city and state to Tom Novelli, VP of Government Affairs, MDMA. 

Regarding Pioneer’s latest product introduction, Raleigh based Shane Ray, General Manager – Biologics for Pioneer stated, “We are very pleased to expand our product offerings with nanOss Bioactive Loaded. We strive to meet surgeon needs and our customers asked for an MIS delivery option."  Read more here. 

Read this article in MedCity news as the Raleigh based diagnostic company plans to go public.