The US FDA has cleared the Pentax Medical Video ED34-i10T2, the first duodenoscope for the US market with a sterile, disposable elevator component designed to reduce the number of parts that need to be disinfected between uses. See what Jeff Shuren, director of the agency’s device center, said about it here.

A manufacturer of in vitro diagnostic reagents was cited for premarket violations in the only device-related warning letter released by the US FDA this week.

The US FDA cleared Pentax Medical’s new duodenoscope as the first in the US with a disposable elevator part that reduces the number of parts needed to be disinfected compared to earlier designs.

US FDA scientists and immunological experts discussed the latest science regarding patients’ biological reactions to metal implants and mercury in dental amalgam at a 13-14 November agency advisory committee meeting. The get-together was held to determine what additional actions the FDA can take to make sure certain patients are protected from immunological risks of the implants. The panel ultimately backed a transition away from mercury amalgam dental fillings and pushed for more research into risks associated with metal implants.

Medical device manufacturers often stumble when conducting process validation activities. In this Q&A, former US FDA investigations branch director Ricki Chase explains what those hurdles are and offers tips to firms to make sure they’re on the road to compliance.

Let’s be blunt: Device-makers aren’t particularly fond of facility inspections by the US FDA. From audits that can sometimes drag on for weeks to nightmarish inspections well-documented by industry experts, there’s no shortage of tales of investigators that were difficult to handle. But the agency’s ongoing rewrite of its Quality System Regulation to harmonize it with international standard ISO 13485 could “soften FDA’s inspectorate,” NSF International’s Brian Ludovico says. Also: How might the FDA’s Quality System Inspection Technique (QSIT) change, post-harmonization?

A manufacturer of in vitro diagnostic reagents was cited for premarket violations in the only device-related warning letter released by the US FDA this week.

Medical device manufacturers often stumble when conducting process validation activities. In this Q&A, former US FDA investigations branch director Ricki Chase explains what those hurdles are and offers tips to firms to make sure they’re on the road to compliance.

Let’s be blunt: Device-makers aren’t particularly fond of facility inspections by the US FDA. From audits that can sometimes drag on for weeks to nightmarish inspections well-documented by industry experts, there’s no shortage of tales of investigators that were difficult to handle. But the agency’s ongoing rewrite of its Quality System Regulation to harmonize it with international standard ISO 13485 could “soften FDA’s inspectorate,” NSF International’s Brian Ludovico says. Also: How might the FDA’s Quality System Inspection Technique (QSIT) change, post-harmonization?

Sweden's Recipharm has agreed to buy UK-based Consort Medical for £505m ($652m) to become a leading inhalation-device company and top five global CDMO. 

Medtech Insight features its shortlist of top innovators who showcased their products at the recent Exponential Medicine conference in San Diego.

Nypro, a Jabil Company, offers design, engineering, supply chain and manufacturing services for the medical device, diagnostics, pharmaceutical and consumer health markets. In a contributed analysis, Jabil/Nypro's Joe McBeth, Erich Stein, Brad Womble and Doug Bond suggest the medical device industry has been relatively slow to adopt connected technologies, and must be ready to adapt more quickly in the future.

In this week's podcast, Medtech Insight managing editor Marion Webb summarizes her recent interviews with Ted Tanner, CTO of IBM Watson Health, and Catherine Mohr, president of the Intuitive Foundation, during the Exponential Medicine conference in San Diego. And deputy editor Reed Miller discusses the appointment of Robert Ford as the new CEO of Abbott Laboratories, the latest in a recent series of high-profile CEO appointments in medtech.

Abbott's CEO Miles White will step down at the end of March 2020 after 21 years on the job. Robert Ford, Abbott's president and COO, will succeed White as Abbott's CEO. See what William Osborn, chair of Abbott's board of directors' nominations and governance committee, said about it here.

Abbott’s current COO Robert Ford will become the company’s new CEO on 31 March, 2020. Miles White is stepping down after 21 years leading the diversified health-care products company.

The US FDA has cleared the Pentax Medical Video ED34-i10T2, the first duodenoscope for the US market with a sterile, disposable elevator component designed to reduce the number of parts that need to be disinfected between uses. See what Jeff Shuren, director of the agency’s device center, said about it here.

Cardiawave's non-invasive ultrasound therapy is feasible and safe in patients with severe symptomatic aortic stenosis, according to early trial results presented at the annual American Heart Association meeting. See what Cardiawave's CEO, Benjamin Bertrand, said about it here.

The US FDA cleared Pentax Medical’s new duodenoscope as the first in the US with a disposable elevator part that reduces the number of parts needed to be disinfected compared to earlier designs.

Medtech giant Medtronic filed a patent infringement suit against Axonics, alleging Axonics' sacral neuromodulation technology infringes four of Medtronic's patents for implantable electrical stimulation lead fixation methods and transcutaneous inductive charging for implantable medical devices. See what Axonics CEO, Raymond Cohen, said about it here.

The US FDA approved Axonics’ r-SNM sacral neuromodulation system for treating overactive bladder and urinary retention on 14 November. The agency approved the same device for treating chronic fecal incontinence on 9 September. Axonics expects r-SNM to rival Medtronic's InterStim II non-rechargeable sacral neuromodulation system, but Medtronic claims the r-SNM technology infringes on Medtronic’s intellectual property.

Ongoing scrutiny has not explained an apparent link between paclitaxel-coated cardiac devices and an increased mortality rate, speakers said at the Vascular Interventional Advances (VIVA) 2019 conference in Las Vegas. See what Krishna Rocha-Singh, a VIVA board member, said about it here.