Pentax Medical announced today that it launched its EB-J10 Series bronchoscopes in the U.S. after receiving FDA 510(k) clearance. The Hoya (TYO:7741) subsidiary’s EB-J10 Series bronchoscopes are designed to provide high-definition visualization of the bronchus and have compatibility with the simultaneously launched Defina video processor for supporting pulmonology practices with advanced imaging. Montvale, N.J.-based Pentax’s EB-J10 […]
Hoya Corp.
Pentax Medical launches Imagina endoscope in U.S.
Hoya (TYO:7741) subsidiary Pentax Medical announced that it won FDA 510(k) clearance for its Imagina endoscopy system and initiated the device’s U.S. launch. The Imagina system is designed to perform gastrointestinal (GI) procedures at ambulatory surgery centers (ASCs). It features a touch-screen LCD interface while eliminating the need for periodic bulb replacements. It also includes the […]
Pentax has a duodenoscope meant to reduce superbug fears — and now it’s for sale in the U.S.
Hoya (TYO:7741) subsidiary Pentax Medical has announced the U.S. launch of its DEC HD duodenoscope, which boasts a sterile, disposable elevator meant to reduce reprocessing challenges associated with the device. The news, released yesterday, comes about a week after FDA announced clearance of the Pentax duodenoscope. The DEC HD duodenoscope has been available in global […]
Novuson Surgical wins backing from Hoya
Ultrasound-tech developer Novuson said on Tuesday that it is receiving funding from Japan’s Hoya Corp. (TYO:7741) to support the finalized development of its direct therapeutic ultrasound (DTU) UltraStat 3mm vessel sealer and divider. The Bothell, Wash.-based company said that the DTU system is a novel approach using a therapeutic modality of ultrasound that avoids the need for […]
FDA: Duodenoscope reprocessing is dirtier than we thought
The FDA said today that new data show that the contamination rate for “high-concern organisms” in duodenoscopes is nearly twice as high as previously thought and warned the devices three major manufacturers to get their required post-market studies in gear. Back in 2015 the federal safety watchdog warned Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary following a string […]
Hoya gets in on $15m round for 3NT Medical
3NT Medical said today that it drummed up “a major portion” of its maiden $15 million funding round from Japan’s Hoya Corp. (TYO:7741) Rosh Ha’Ayin, Israel-based 3NT is developing the Sinusway drivable endoscope for ear, nose and throat procedures. Proceeds from the round are slated for commercializing Sinusway in the U.S. and Europe and the completion of […]
FDA issues warning letters to Olympus, Fujifilm, Pentax over duodenoscope issues
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 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 […]
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 […]
LensGen raises $21m in Series A
Ophthalmic device developer LensGen said today it closed a $21 million Series A financing round to support its Juvene accommodating intraocular lens. The financing round was led by the corporate venture investment arm of Hoya Group and was joined by Relativity Healthcare Partners, the Irvine, Calif.-based company said. “As one of the leading global intraocular […]