Amanda Bloom
Amanda Bloom
Soapbox

MedTech Marketing Pearls for FDA Clearance and Beyond

By Amanda Bloom

As VP of Product Marketing for a MedTech startup, my role is to champion pioneering medical technology, strategically spark interest and drive it out of the design lab and into the field where it will ultimately change, or even save lives. Over the last two decades, I’ve seen the industry evolve in interesting ways, and I’ve learned some enduring lessons about market introduction and launch of market-making technologies post-FDA clearance.

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FDA Logo
FDA Logo

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity

By MedTech Intelligence Staff

The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is hosting a two-day virtual public workshop on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups. The workshop is scheduled for Wednesday, November 29, and Thursday, November 30, 2023, from 10:00am-2:00pm ET.

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Supply Chain and Adv Mfg 2023
Supply Chain and Adv Mfg 2023
From The Editor's Desk

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference

By MedTech Intelligence Staff

Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced Manufacturing Conference and Supply Chain Summit, in partnership with Axendia, Inc. The two events will run back-to-back with registration options available for each program as well as a discounted rate for professionals who would like to attend both programs.

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Maria Shepherd
Maria Shepherd

Perseverance Is Key

By MedTech Intelligence Staff

Maria Shepherd, president and founder of Medi-Vantage and co-founder of MedExecWomen, discusses her career in the medical device industry, what led her to launch her own company and the joy of “finding her tribe” among fellow female executives committed to bringing up the next generation of women leaders in MedTech.

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AVEIR DR
AVEIR DR

FDA Approves Abbott’s Dual Chamber Leadless Pacemaker

By MedTech Intelligence Staff

Results from the AVEIR DR i2i Investigational Device Exemption (IDE) study through three-months post-implant showed a 98.3% implant success rate for physicians and more than 97% of people had a successful atrio-ventricular synchrony, so that the upper and lower chamber were beating normally, despite different types of underlying slow heart rhythms.

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