Archives
Bos Sci Optimistic on Watchman as It Awaits Reimbursement Decision
Medicare’s final decision on reimbursement coverage for Boston Scientific’s Watchman device is expected soon, but management sees a large global market opportunity, whatever the decision.
(February, 2016)
FDA: Gather Human Factors Data for These Devices
Ventricular assist devices, certain duodenoscopes, and infusion pumps are among the “highest priority” devices FDA thinks should include human factors data in premarket submissions. 
(February, 2016)
Stryker's $2.8B Play To Tackle Hospital Acquired Conditions
Stryker is buying Sage Products, which makes a range of products meant to reduce hospital acquired conditions and hospital "never events" that are expensive to treat. 
(February, 2016)
Does Abbott Risk Lower Growth in Becoming a Point-of-Care Giant?
Abbott dramatically expands its point-of-care-diagnostics business with the intended acquisition of Alere, but some analysts are asking how the transaction might impact the company's growth outlook. 
(February, 2016)
More Indications Coming for C.R. Bard's Drug-Coated Balloon
A full year into selling its Lutonix drug-coated balloon catheter, C.R. Bard plots expanded indications for the technology.
(January, 2016)
Global Pressures Impacting Orders for Radiation Oncology Systems
Varian Medical Systems, the market leader in radiation oncology systems, reports weak international orders influenced by tough macroeconomic factors. 
(January, 2016)
Stryker to Build New 3-D Printing Manufacturing Facility in 2016
3-D printing won't replace Stryker's regularly manufactured knees and hips business any time soon, but it helps to build novel products that provide a competitive edge.
(January, 2016)
Medtech's Biggest Deals of 2015
The most shocking megamergers may be behind us, but the trend toward consolidation in medtech continued last year.
(January, 2016)
Can J&J Stem the Bleeding in its Medical Device Business?
There's more to CEO Alex Gorsky's turnaround strategy than slashing jobs and restructuring, but will it work? 
(January, 2016)
Cloud Integration Company Unveils Health IT Platform
Jitterbit, a major cloud integration vendor, is turning its attention to healthcare interoperability for patient data, connected devices, and apps. 
(January, 2016)
Can This Spinal Fusion Technology Rise from the Ashes?
AxiaLIF initially fell victim to coding woes and scandal, but a new group of investors believes the spinal fusion technology is worth fighting for.
(January, 2016)
Smaller Devices Drive Big Changes in Medical Molding
Molders are adjusting their equipment and techniques to address the trend of tinier medical devices.
(January, 2016)
New Devices Aim to Prevent Pressure Ulcers
New device approaches are being tested to tackle the problem of pressure ulcers that are bad for hospital business and can be life threatening for patients. 
(January, 2016)
FDA: Pick a Sterilization Method, but Not Just Any Method
The agency has issued final guidance on how it intends to address novel sterilization processes used for devices labeled as sterile and submitted for 510(k) clearance.
(January, 2016)
3 Things to Consider When Using Off-the Shelf Software
Medical device makers using off-the-shelf commercial software need to consider these 3 things when deploying them in medical environments.
(January, 2016)
A Must-Read For Those Interested in Cybersecurity of Connected Devices
If you are trying to mitigate cyber risk in connected devices, pay attention to how medical data residing in hospitals can be hijacked. 
(January, 2016)
J&J to Ax Up to 6% of Device Workforce; M&A Inevitable
Johnson & Johnson is cutting jobs at its lackluster medical device business and an analyst predicts that the company will do acquisitions to rev up its device business. 
(January, 2016)
Could UDI Have Prevented Infectious Outbreak?
This week's Senate report on the superbug-contaminated duodenoscopes highlighted the potential benefits of including unique device identifiers in insurance claims.
(January, 2016)
Chrono Therapeutics’s Wearable Device Aims to Help Smokers Quit
The company’s wearable smoking cessation device enables users to log cravings and tides them over with algorithm-dosed nicotine.
(January, 2016)
Longer Timeline, Little Clarity for HeartWare's MVAD
New cases of pump thrombus and the potential for design changes mean further delays for the next-generation MVAD from HeartWare.
(January, 2016)
Medtronic Partners with Local Chinese Government to Manufacture Insulin Pumps
Medtronic will invest in a new manufacturing plant in China that will manufacture a sensor-augmented insulin pump and sell it to diabetics in the region. 
(January, 2016)
AMA Seeks 'Purposeful Disruption,' Invests in New Healthcare Startup
The American Medical Association is the founding investor in a new Caliornia startup that will leverage the insight of physicians to bring products into the healthcare marketplace. 
(January, 2016)
Large GeneDx Study Supports Multigene Panel Testing
A study of over 10,000 patients tested with a multigene hereditary cancer panel finds that the approach commonly spots hereditary cancer-linked gene variants that single gene tests might miss.
(January, 2016)
The $279 Billion Healthcare Opportunity You Should Be Targeting
While healthcare companies strive to appeal to patients and clinicians, family caregivers are largely overlooked.
(January, 2016)
5 Keys to Winning a Medical Design Excellence Award
Craig Scherer, an MDEA juror and cofounder of the seven-time MDEA-winning design firm Insight Product Development, shares tips for increasing the odds of going home with the gold.
(January, 2016)