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US FDA recently qualified the OsiriX CDE Software Module as a Medical Device Development Tool (MDDT), making it the third MDDT qualified by the agency and the first biomarker MDDT. See what FDA Commissioner Scott Gottlieb said about it here.
In this week's Results Recap, covering trial data from the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, Martin Leon from Columbia University presented results from the PARTNER 3 trial, comparing Edwards Lifesciences Corp.'s balloon-expandable Sapien 3 transcatheter aortic valve system to open valve surgery. See what Martin Leon from Columbia University said about it here.
In this week's Results Recap covering trial data from the American Academy of Orthopedic Surgeons Annual Meeting in Las Vegas March 12-16, Myoscience released encouraging preliminary results from a 125-patient study on its Iovera cryoanalgesia therapy. See what the presenter of the results, William Mihalko, from Campbell Clinic of Germantown, Tennessee, said about it here.
In this week's Starts & Stops compilation of clinical trial announcements, Stereotaxis and Acutus Medical announced the companies have successfully treated the first heart patient with an integrated robotic magnetic navigation and non-contact mapping system. See what Tamas Szili-Torok of the Erasmus Medical Center in Rotterdam, Holland, said about it here.
US FDA is approving 30-day change notices at a breakneck pace for device-makers enrolled in an agency program that measures manufacturing maturity and quality. See what FDA's Cisco Vicenty said about it here.
Cardiva Medical believes it's in a unique position to help the growing number of patients who undergo catheter-based cardiovascular procedures requiring relatively large catheters, especially electrophysiology procedures like cardiac ablation. See what Cardiva CEO John Russell said about EP procedures here.
The current annual global manufacturing market for liquid biopsy is roughly $170m – representing a 90% yearly increase since 2015 – and it's expected to reach about $1bn by 2023. See what DeciBio Consulting's Mika Wang said about it here.
Norman "Ned" Sharpless, director of the National Cancer Institute, will lead US FDA as its acting commissioner when agency head Scott Gottlieb steps down next month. See what Health and Human Services Secretary Alex Azar said about the appointment here.
Continuous glucose monitor company Senseonics Holdings Inc. has named Francine Kaufman as chief medical officer. See what Senseonics President and CEO Tim Goodnow said about Kaufman's appointment here.
Outgoing US FDA Commissioner Scott Gottlieb does not want the agency hierarchy shook up once he departs, preferring "to keep the FDA team intact." See what else he said here.
The market for breast cancer imaging, biopsy and tissue-sparing treatment products is expected to reach $5.8bn in 2022, a CAGR of 5.9% from 2017. Many radiologists believe that digital breast tomosynthesis will become the gold standard. See what Kaiser Permanente's radiologist Ifeanyi Onyeacholem said about it here.
Electrocardiography (ECG) trial data by iRhythm Technologies Inc.'s Zio ambulatory continuous-care wearable ECG monitor analyzed by artificial intelligence showed that it can detect cardiac arrhythmias as effectively as a panel of expert cardiologists. See what iRhythm's EVP for R&D Mark Day said about it here.
Changes to the US Department of Veterans Affairs' medical and surgical supply purchasing program could open new opportunities for device makers, but also present drawbacks. See what Roger Waldron, president of the Coalition for Government Procurement, said about it here.
Siemens Healthineers AG revealed its new 'one-stop shop' system for stroke at the annual European Congress of Radiology (ECR) in Vienna. See what Siemens Global Product Manager, Peter Hildebrandt, said about it here.
US agencies CMS, FDA and CDC have formed a new task force to help accelerate diagnostics for public health emergencies. CMS official Kate Goodrich talks about one goal of the effort here.
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