The FDA said today it issued warning letters to Olympus (TYO:7733), Fujifilm Holdings (TSE:4901), and Hoya‘s Pentax Medical over failures to comply with federal orders to conduct postmarket surveillance studies to assess the effectiveness of reprocessing duodenoscopes. The order, issued by the federal watchdog in 2015, required all three manufacturers to conduct postmarket surveillance studies to determine whether healthcare […]
Pentax
Pentax Medical recalls ED-3490TK duodenoscopes
Hoya‘s Pentax Medical is recalling its ED-3490TK duodenoscopes looking to replace parts of the scopes to prevent leakage of patient fluids into the device, according to an FDA release. The company is looking to replace the forceps elevator mechanism, o-ring seal and distal end covering to prevent leakage of fluids into the closed elevator channel and under […]
Pentax adds ASHA’s voice problem assessment tools into voice and speech software
Hoya‘s Pentax Medical said today it inked a licensing agreement with the American Speech-Language-Hearing Association to incorporate a tool it designed to help assess voice problems into a software modules used in Pentax’s voice and speech assessment products. The Consensus Auditory-Perceptual Evaluation of Voice tool was developed by the ASHA to “provide a standardized protocol and […]
Pentax Medical wins CE Mark for DEC duodenoscope
Hoya‘s Pentax Medical said today it won CE Mark approval in the European Union for its DEC duodenoscope featuring a disposable elevator cup. The Tokyo-based company said the new device features a combination of advanced cleaning capabilities and improved infection prevention controls to ensure a more reliable performance. The new device also features improved high definition […]
7 medtech stories we missed this week: August 11, 2017
From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions […]
Pentax Medical, Aohua ink JV endoscopy deal
Hoya‘s Pentax Medical said today it inked a joint venture deal with Shanghai Aohua Photoelectricity to develop flexible medical endoscopy products. The new JV company will look to offer endoscopy solutions with an initial focus on “needs of emerging markets,” according to Tokyo-based Pentax. “With Pentax Medical as our partner, this joint venture provides Aohua […]
FDA warns again on Pentax duodenoscopes
The FDA issued a statement today warning that Hoya (TYO:7741) subsidiary Pentax Medical’s ED-3490TK video duodenoscopes have a potential risk associated with the design and manufacturing of the device. Cracks in the adhesive that seals the scope’s distal cap and tip can lead to microbial and fluid ingress, according to information provided to the FDA by Pentax. […]
Report: CVRx CEO Yared tapped for AdvaMed chairman | Personnel Moves for June 27, 2016
Report: CVRx CEO Yared tapped to succeed BD’s Forlenza as AdvaMed chairman Nadim Yared, the CEO of CVRx, is reportedly slated to replace Becton Dickinson (NYSE:BDX) chief executive Vincent Forlenza as chairman of AdvaMed, the medical device industry’s national lobby in Washington. It’s the 1st time the Advanced Medical Technology Assn. will have a small company’s […]
Pentax Medical picks up controlling stake in Simmedica
Hoya (TYO:7741) subsidiary Pentax Medical said today it acquired over 90% of the shares in Spanish and Portugeuese endoscopy and surgery product and service company Simmedica. Pentax Medical said it made the decision to acquire a majority ownership in the company based upon an increase in sales volume and service over the recent years. “I am delighted that […]
Pentax updates on FDA-cleared scope labeling to fight “superbugs”
The FDA said it cleared updated reprocessing instructions for Pentax’s ED-3490TK video duodenoscopes to avoid infectious outbreaks of “superbugs.” Duodenoscopes are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More than 500,000 ERCPs using the devices are performed in the U.S. […]
Senate report faults hospitals, device makers, FDA for deadly ‘superbug’ outbreaks
A report by Democrats on the U.S. Senate’s health committee issued this week blames hospitals, medical device companies and the FDA for the deadly outbreaks of so-called “superbug” infections linked to duodenoscopes. The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of […]
