Search Results for “medical device” – Page 21 – media

Hamilton Medical’s urgent ventilator notice deemed Class I recall by FDA

Dive Brief Hamilton Medical’s recall of ventilators for a software problem was designated Class I by the U.S. Food and Drug Administration, the agency wrote in a Monday notice. Hamilton contacted customers in June after learning that its C1, C2, C3 and T1 ventilators switch to “ambient state” if used in neonates for more than 91 days without a restart. In ambient state, the device sounds an alarm and no active ventilation is provided to patients. In light of the fault, which has caused 80 complaints but no injuries or deaths, Hamilton is asking users of its ventilators to regularly restart their devices. Dive Insight Hamilton sells mechanical ventilators for use in adults, children and infants. The problem that caused the Class I recall happens when the devices “are used for long-term ventilation in neonatal group.” If the ventilation time exceeds 91 days, the devices enter ambient state, causing them ...
- Source: drugdu
- 129
- September 4, 2023
Trade groups urge CMS to expand, quickly finalize breakthrough device pathway

Dive Brief Medtech trade groups have voiced support for the Centers for Medicare and Medicaid Services’ plan to accelerate reimbursement of certain breakthrough devices. In letters sent on the same day, AdvaMed and the Medical Device Manufacturers Association (MDMA) urged CMS to quickly finalize the program, while also naming changes they want the centers to make. The trade groups recommended changes including the expansion of the CMS program to cover breakthrough diagnostics, products authorized in the previous three years and medical devices that are nearing approval. Dive Insight In June, CMS released a draft version of the Transitional Coverage for Emerging Technologies (TCET) pathway for consultation. The path could fill a gap created by the repeal of the contentious Medicare Coverage for Innovative Medical Technologies plan and address industry calls to cut the gap between device approval and reimbursement. AdvaMed and MDMA submitted feedback on the new proposal to CMS ...
- Source: drugdu
- 148
- September 1, 2023
Medtronic’s dialysis device recall assigned to Class I by the FDA

Dive Brief Medtronic’s recall of hemodialysis catheters was categorized by the U.S. Food and Drug Administration as a Class I event, according to a Friday entry in the FDA’s database. The company contacted customers in June after routine manufacturing testing identified a blockage that could obstruct the catheter, potentially delaying treatment and leading to outcomes such as blood clots and the destruction of red blood cells. Healthcare providers with devices covered by the recall should immediately quarantine and stop use of the catheters. Medtronic has received no confirmed complaints related to the problem, and no reports of adverse events or deaths. Dive Insight The Medtronic recall affects specific lots of Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple Lumen Catheters. Medtronic’s Mahurkar Elite Catheters are unaffected by the recall. “Medtronic initiated a voluntary recall related to Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple ...
- Source: drugdu
- 148
- August 18, 2023
Delcath Gets FDA Approval for Cancer Drug-Device Combo 10 Years After Rejection

By Tristan Manalac Pictured: Cancer cells growing on the liver/iStock, Rasi Bhadramani The FDA on Monday approved Delcath Systems’ Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma, capping a nearly decade-long effort to secure regulatory approval. Hepzato’s label covers metastatic uveal melanoma (mUM) patients with unresectable hepatic metastases that afflicts less than 50% of their liver and who do not show signs of extra-hepatic disease. Hepzato can also be used in cases of extra-hepatic spread, provided it is limited to the bone, lymph nodes, subcutaneous tissues or lungs. Monday’s approval makes Hepzato “the only liver-directed therapy that can treat the whole liver,” Delcath Chief Medical Officer Vojislav Vukovic said in a statement. The approved product comes with a boxed warning for severe peri-procedural complications, such as hemorrhage and hepatocellular injury, as well as myelosuppression. To manage these risks, the company will implement a Risk Evaluation ...
- Source: drugdu
- 112
- August 18, 2023
Medtronic’s bid to dismiss heart device kickback claims fails, clearing case to advance

“This is a preliminary ruling in the case and Medtronic is confident that the full body of evidence, as the case moves ahead, will demonstrate that the claims have no merit. “Each patient seen at the Robert J. Dole VA Medical Center for a Peripheral Arterial Disease interventional procedure was referred by other doctors because of the patient’s medical condition. Moreover, the physicians performing these procedures used FDA-approved devices from a variety of manufacturers and the physicians were salaried and received no additional compensation for the procedures or using the devices. “Medtronic follows all applicable laws and policies to ensure our interactions with physicians are principled and appropriate.” Dive Brief Medtronic’s attempt to dismiss whistleblower accusations that it violated the False Claims Act has largely failed, with a court ruling on Thursday that most of the claims can advance. The whistleblower accused Medtronic of billing the government for unnecessary medical ...
- Source: drugdu
- 237
- August 17, 2023
What the New CMS Payment Proposals Mean for Device Makers

Dive Brief The Centers for Medicare and Medicaid Services shared a pair of proposed rules on Thursday afternoon that set rates for physician payments and outpatient procedures. The agency issued the 2024 Hospital Outpatient Prospective Payment System and 2024 Physician Fee Schedule proposed rules, both of which are expected to be finalized this fall. Glaukos could be the biggest beneficiary of the proposals among device makers, with an increase in outpatient facility fee rates likely to provide a “meaningful boost” for its iStent device to treat patients with glaucoma, BTIG analyst Ryan Zimmerman wrote in a research note on Thursday. Dive Insight The two payment proposals include reimbursement increases for some medical device companies, and cuts for others. San Clemente, Calif.-based ophthalmic device company Glaukos is among those who stand to benefit. Its ambulatory surgical center facility fee for the iStent infinite device was nearly doubled ...
- Source: drugdu
- 136
- July 17, 2023
Health insurance stocks slide after UnitedHealth warns more surgeries will drive up medical costs

Health insurer stocks dropped Wednesday after UnitedHealth Group warned of higher medical costs as older Americans start to catch up on surgeries they delayed during the Covid-19 pandemic. Shares of UnitedHealth, the largest U.S. health-care provider by market value, closed around 6% lower. Medicare-focused insurer Humana declined 11%. Elevance Health closed roughly 7% lower, and CVS Health, which owns insurer Aetna, slid nearly 8%. Insurance companies have benefited in recent years from a delay in nonurgent procedures due to hospital staffing shortages and the pandemic, which saw hospitals inundated with Covid patients. Hospitals at that time were widely seen as too risky to enter for elective procedures. But on Tuesday, UnitedHealth executives indicated that trend may be reversing. The company has recorded “strong outpatient care activity” throughout April, May and the early part of June, Chief Financial Officer John Rex said at a Goldman Sachs health-care conference. Most of the ...
- Source: drugdu
- 106
- June 17, 2023
New devices could help Penumbra take market share, according to physician survey

Dive Brief Penumbra is expected to retain and take market share in the peripheral vascular market over the next 6 to 18 months, according to a survey of physicians by J.P. Morgan analysts. The firm surveyed 25 vascular surgeons, who forecast that Penumbra will take share as the broader peripheral market is expected to grow. “New products should drive share capture across both arterial and venous,” J.P. Morgan analyst Robbie Marcus wrote in a Thursday research note, although the majority of doctors surveyed expect to continue using devices from multiple manufacturers even when targeting the same vessels. Dive Insight Alameda, Calif.-based Penumbra recently launched two new thrombectomy devices: Lightning Bolt 7, which is designed to remove clots from the arteries, and Lightning Flash, which is designed for the veins and pulmonary arteries. The surgeons’ reception to both devices was “broadly positive,” Marcus wrote, with the majority saying they expected Lightning ...
- Source: drugdu
- 229
- June 10, 2023
Novo Nordisk says in talks to acquire French device-maker Biocorp for $165M

Dive Brief Novo Nordisk said it is in exclusive talks to buy French medical device company Biocorp. Novo Nordisk will buy out Biocorp’s main shareholder, Bio Jag, for 35 euros per share, and then make a tender offer for any outstanding shares at the same price, the companies said Monday. The offer would value all of the company at 154 million euros ($165 million). Denmark-based Novo Nordisk, which makes pharmaceutical products and insulin pens, has been collaborating with Biocorp since 2021 on a smart pen cap that tracks information on dose, date and time of injection. Dive Insight Novo Nordisk wants to innovate faster and develop new connected devices, and expects that Biocorp would complement its internal efforts, said Marianne Ølholm, Novo Nordisk’s senior vice president of devices and delivery solutions. Novo Nordisk will work with Biocorp to invest in new devices and drug delivery solutions for people with chronic ...
- Source: drugdu
- 131
- June 8, 2023
EPA proposes new regulations on toxic gas used to sterilize spices and medical equipment

By Brenda Goodman, CNN Updated 2:49 PM EDT, Tue April 11, 2023 The US Environmental Protection Agency on Tuesday proposed a set of new restrictions on facilities that use the cancer-causing chemical ethylene oxide, a colorless, odorless gas that is used to sterilize medical devices and spices. The agency said the new rules, which have not been finalized, would help to reduce ethylene oxide gas that these facilities release by 80%, bringing emissions below a Clean Air Act standard for elevated cancer risk. Communities exposed to ethylene oxide gas have been pushing the EPA to put tighter controls on plants that use ethylene oxide gas. In 2018, an EPA report found that dozens of communities across the nation faced elevated cancer risks because of trace of amounts of ethylene oxide released into air as part of the sterilization process. The EPA issued the report on the new risks without issuing a news release, as ...
- Source: drugdu
- 181
- April 13, 2023

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