Inspire(INSP)
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Inspire Medical Systems, Inc. Announces CE Mark Certification of Full-Body MRI Compatibility under the European Union's Medical Device Regulation
GlobeNewswire News Room· 2024-07-19 12:00
MINNEAPOLIS, July 19, 2024 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), today announced that the European Union Medical Device Regulation (EU MDR) has approved additional magnetic resonance imaging (MRI) scan conditions for use with Inspire therapy. This full-body MRI approval expands the Inspire use labeling t ...
Inspire Medical Systems, Inc. Announces CE Mark Certification under the European Union's Medical Device Regulation for Inspire Therapy
GlobeNewswire News Room· 2024-07-19 12:00
"Inspire has a long history of compliance to the European Union's (EU) quality system and CE mark requirements, with uninterrupted CE mark approval since 2010," said Tim Herbert, Chairman and President of Inspire. "The Inspire team has worked diligently with our notified body in Europe to complete the review process, which included obtaining temporary approval through derogation authorization to continue to deliver Inspire product in several countries." There are two changes to Inspire therapy that are now ...
INSPIRE MEDICAL ALERT: Bragar Eagel & Squire, P.C. is Investigating Inspire Medical Systems, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2024-07-18 01:00
NEW YORK, July 17, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Inspire Medical Systems, Inc. (NYSE: INSP) on behalf of long-term stockholders following a class action complaint that was filed against Inspire Medical on December 22, 2023 with a Class Period from May 3, 2023 to November 7, 2023. Our investigation concerns whether the board of directors of Inspire Medical have breached their fiduciary dutie ...
Inspire Medical (INSP) Dips on FDA Recall of IPG Model 3028
ZACKS· 2024-07-10 16:11
Inspire Medical Systems Inc. (INSP) has issued a recall of its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a critical manufacturing defect. The FDA has classified this as the most serious type of recall, as the defect can lead to electrical leakage in the sensing circuit post-implantation. This leakage can cause system malfunctions, potentially resulting in severe health consequences, including inconsistent stimulation, painful shocks or even death. There may be an urgent need for revisio ...
FDA Labels Inspire Medical's Sleep Apnea Nerve Stimulator Recall As Most Serious
Benzinga· 2024-07-09 19:17
There have been no reported injuries. There have been no reports of death. The IPG works with external programmers that allow the physician to set and adjust the therapy parameters and the patient to control the therapy's activation and intensity. Loading... The FDA has labeled a recall of Inspire Medical Systems, Inc.'s INSP nerve-stimulating implant for obstructive sleep apnea as Class I, the most serious kind. Inspire Medical Systems is recalling Inspire IV Implantable Pulse Generator (IPG) Model 3028 du ...
Inspire Medical Systems, Inc. to Report Second Quarter 2024 Financial Results on August 6, 2024
Newsfilter· 2024-07-02 12:00
If you plan to ask a question, please use the following link: Inspire's Q2 2024 earnings call. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call. Following the call, a replay will be available on the Company's Investor Relations website approximately two hours after the ...
Inspire Medical Systems, Inc. to Report Second Quarter 2024 Financial Results on August 6, 2024
GlobeNewswire News Room· 2024-07-02 12:00
MINNEAPOLIS, July 02, 2024 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire) will release financial results for the second quarter 2024 after the close of trading on Tuesday, August 6. Inspire's management team will host a corresponding conference call beginning at 5:00 p.m. Eastern Time to discuss the financial results and recent business developments. Following the call, a replay will be available on the Company's Investor Relations website approximately two hours after the event an ...
Why Is Inspire (INSP) Down 7.3% Since Last Earnings Report?
ZACKS· 2024-06-06 16:36
A month has gone by since the last earnings report for Inspire Medical Systems (INSP) . Shares have lost about 7.3% in that time frame, underperforming the S&P 500. Will the recent negative trend continue leading up to its next earnings release, or is Inspire due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. Inspire Medical Q1 Earnings Beat, Gross Mar ...
Inspire Medical Systems, Inc. to Present at the Truist Securities Medtech Conference
Newsfilter· 2024-06-04 12:00
MINNEAPOLIS, June 04, 2024 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE:INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea, announced today that its management team will present at the Truist Securities Medtech Conference on Tuesday, June 18, 2024. Inspire is scheduled to present at 10:40 a.m. Eastern Time. The presentation will be accessible via a live webcast here. A ...
Three Reasons to Retain Inspire Medical (INSP) Stock for Now
zacks.com· 2024-05-21 17:40
Inspire Medical Systems, Inc. (INSP) is well-poised for growth in the coming quarters, courtesy of its focus on research and development (R&D). The optimism led by a solid first-quarter 2024 performance and its global presence are expected to contribute further. However, concerns regarding overdependence on the Inspire system and a competitive landscape prevail. Over the past year, this Zacks Rank #3 (Hold) stock has lost 49.3% compared with the 25.3% decline of the industry. The S&P 500 has witnessed 26.7% ...